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Comments for Judge Lipman on the MDH proposed rule on vaccinations.
Jerri Johnson
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NELLCO Legal Scholarship Repository
New York University Public Law and Legal
Theory Working Papers
New York University School of Law
9-1-2010
Reconsidering Compulsory Childhood
Vaccination
Mary Holland
NYU School of Law, [email protected]
Recommended Citation
Holland, Mary, "Reconsidering Compulsory Childhood Vaccination" (2010). New York University Public Law and Legal Theory
Working Papers. Paper 226.
http://lsr.nellco.org/nyu_plltwp/226
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Reconsidering Compulsory Childhood Vaccination
Mary Holland1
NYU School of Law
245 Sullivan Street, C-12
New York, NY 10012
212-998-6212
[email protected]
September 10, 2010
ABSTRACT
The laws that govern childhood compulsory vaccination deprive parents and
children of three ordinary tort law protections: free and informed consent to an
invasive medical procedure; accurate and complete information about vaccine
ingredients and possible side effects; and the right to sue manufacturers and
medical practitioners directly in the event of injury. While these atypical tort
law standards have been adopted and upheld for the public good, this article
argues that they have caused unintended and undesirable consequences. These
effects include unnecessary compulsory childhood vaccinations; conflicts of
interest in national vaccine policy; inadequate vaccine safety; inadequate
warnings about vaccine risks; insufficient compensation for vaccine-induced
injury; and other undesirable outcomes. The article offers a new interpretation
of the landmark Supreme Court case, Jacobson v. Massachusetts, that
recognizes constitutional limitations on compulsory vaccination, and sheds light
on the key federal statute, the National Childhood Vaccine Injury Compensation
Act.
1
Director, Graduate Legal Skills Program. I am grateful to the NYU Lawyering Program
Colloquium and the Center for Personal Rights Colloquium for opportunities to discuss this
article. Special thanks to Kevin Barry, Joy Radice, Kim Mack Rosenberg, Jenny Roberts and
Juliet Stumpf for critique. I am grateful to Heather Groves for invaluable research assistance.
Reconsidering Compulsory Childhood Vaccination
INTRODUCTION .............................................................................................. 2
I. State Police Power to Compel Childhood Vaccination ......................... 4
A. Judicial Decisions before Jacobson v. Massachusetts…………...4
B. Jacobson v. Massachusetts............................................................ 6
C. Jacobson's Application.................................................................. 9
1. Zucht v. King: Applying Jacobson to School Mandates ...... 10
2. Early Interpretation of Jacobson .......................................... 11
3. Later Interpretation of Jacobson .......................................... 12
D. Scholarly Interpretation of Jacobson’s Legacy ........................... 14
E. Legal Developments Leading to the 1986 Law ........................... 15
1. Advisory Committee on Immunization Practices (ACIP) ... 16
2. Vaccine Injury Litigation ..................................................... 17
II. The 1986 Law....................................................................................... 21
III. The Effects of U.S. Vaccine Laws……………………….………… 24
A. Inadequate Safety ......................................................................... 26
1. Inadequate Vaccine Testing ................................................... 27
2. Dangerous Vaccine Additives................................................ 28
3. Failure to Screen Vulnerable Subjects ................................... 29
4. Insufficient Incentives and Funding for Vaccine Safety…… 29
5. Government Discouragement of Public Discourse ................ 30
B. Failure to Compensate Vaccine Injury Victims Generously .......... 31
C. . Failure to Provide Accurate Information………………………….33
D. Conflicts of Interest and Troubling Aspects of the Vaccine Ind.... 34
1. Conflicts of Interest................................................................ 34
2. The Pharmaceutical Industry ................................................. 36
E. Children’s Health Problems ......................................................... 40
IV. Reinterpreting Jacobson and Amending the 1986 Law ......................... 41
CONCLUSION .................................................................................................. 44
1
In 1995, within hours of receiving a diphtheria, tetanus and pertussis vaccine, infant
Hannah Bruesewitz had life-threatening seizures. She continues to suffer severe seizures and
multiple impairments. Her parents timely filed a claim in the Vaccine Injury Compensation
Program (VICP) but they were denied compensation for failure to prove causation. The family
then sued in civil court on a vaccine design defect theory. The district court dismissed the claim
and the Third Circuit Court of Appeals affirmed. The U.S. Supreme Court will hear her appeal
on October 12, 2010. It will decide whether the Bruesewitzes have the right to sue the vaccine
manufacturer in civil court under the 1986 National Childhood Vaccine Injury Compensation
Act.2
INTRODUCTION
“Vaccines save lives” is what American government, medicine and culture teach us.
While true for the majority, it is also true that vaccines may injure, disable and cause death to
some. Compulsory vaccination of children spotlights the moral and legal limits on state coercion
of individuals. How far can the government go to compel vaccination? Whom may it compel?
And on what grounds? And when vaccines do cause permanent damage, who bears the financial
cost? And if vaccines are defective, what then? These questions potentially affect millions of
Americans as almost all children receive 30-45 compulsory vaccines to attend school.3 More
than ten thousand people have sought compensation for vaccine injury to date.4 The U.S.
Supreme Court will hear issues bearing on vaccine injury in October, 2010 in Bruesewitz v.
Wyeth, the case briefly outlined above.
The purpose of compulsory vaccination is to protect children and the public from
infectious disease. Indeed, vaccines are widely credited as one of the most important
contributions of modern medicine.5 The role of vaccines in protecting children and the public
may be overstated, however, in that the mortality rates from infectious disease dropped
precipitously in the twentieth century before almost any vaccines were in widespread use in the
2
Bruesewitz v. Wyeth Inc., 561 F.3d 233 (3rd Cir. 2009), cert. granted, 130 S. Ct. 1734 (2010).
See National Network for Immunization, State Requirements, http://www.immunizationinfo.org/vaccines/staterequirements.
4
National Vaccine Injury Compensation Program, Statistics Report, Health Resources and Services Administration
(July 14, 2010), http://www.hrsa.gov/vaccinecompensation/statistics_report.htm (reporting that 13,479 petitions
were filed between fiscal years 1988 and 2010, 7,409 petitions have been dismissed and 2,472 have been
compensated as of July 14, 2010).
5
Ten Great Public Health Achievements – United States, 1900-1999, MORBIDITY & MORTALITY WKLY R. (1999),
http://www.cdc.gov/mmwr/preview/mmwrhtml/00056796.htm (listing vaccination first).
3
2
United States.6 These dramatic declines were likely due to better sanitation, cleaner water, better
overall nutrition and the availability of antibiotic and antiviral medicines.7
Compulsory vaccination laws have been a central pillar of government policy because the
government attributes near eradication of childhood infection diseases primarily to universal
vaccination. But while compulsory vaccination may serve the greater good, state and federal
laws deprive American school children and their parents of three ordinary tort law protections:
free and informed consent to an invasive medical procedure; accurate and complete information
about vaccine ingredients and possible side effects; and the right to sue manufacturers and
medical practitioners directly in the event of injury.8 The absence of these legal protections is
striking compared to almost all other medical interventions. Because of the perceived
overwhelming benefit from vaccines, U.S. federal and state law treat compulsory vaccination of
children in a radically different way. Compulsory childhood vaccination is the most salient
deviation from the ethical and professional standard of informed consent in civilian medicine.
Three laws are at the core of the national childhood vaccine program: Jacobson v.
Massachusetts, a landmark 1905 Supreme Court decision; Zucht v. King, a 1922 Supreme Court
case; and the 1986 National Childhood Vaccine Injury Compensation Act (the 1986 Law or
Law). Jacobson established a state’s police power to compel vaccination.9 Zucht upheld
vaccination mandates as a condition for school attendance.10 And the 1986 Law created the
modern national vaccine program: the infrastructure for mass childhood vaccination;11
insulation of vaccine manufacturers and medical practitioners from ordinary tort liability;12
removal of the right to accurate and complete information;13 establishment of a program to
compensate vaccine-injured victims;14 and the obligation to make safer vaccines.15
The legal framework for compulsory childhood vaccination is similar in some ways to
the legal regimes for housing finance, banking and oil drilling which have recently experienced
severe crises.16 Like those sectors, the vaccine industry has largely ‘captured’ its regulators; the
6
See, e.g., Gregory L. Armstrong et al., Trends in Infectious Disease Mortality in the United States During the 20th
Century, 281 J. AM. MED. ASS'N (Jan. 6, 1999), http://jama.ama-assn.org/cgi/ content/full/281/1/61 (including
graphs showing steep declines in infectious disease in the twentieth century).
7
Id. at Comment section (“During the first 8 decades of the 20th century, the infectious disease mortality rate in the
United States declined substantially….Improvements in living conditions, sanitation, and medical care probably
accounted for this trend.”)
8
42 U.S.C. § 300aa-1 et seq. (2010)
9
Jacobson v. Massachusetts, 197 U.S. 11 (1905).
10
Zucht v. King, 260 U.S. 174 (1922).
11
National Childhood Vaccine Injury Compensation Act, 42 U.S.C. § 300aa-2 (1986 Law).
12
Id. § 300aa-11.
13
Id. § 300aa-22(c) (removing manufacturer liability for failure to directly warn injured parties of dangers that may
result from administration of vaccines); Id. § 300aa-26 (requiring Secretary to disseminate information).
14
Id. § 300aa-10.
15
Id. § 300aa-27.
16
See, e.g., Credit Crisis – The Essentials, N.Y. TIMES, July 12, 2010, at http://topics.nytimes.com/top/
reference/timestopics/subjects/c/credit_crisis/index.html (noting that President Obama, during his campaign, blamed
3
sector is deemed ‘too important to fail;’ credible experts recognize serious safety concerns; and
designated corporate and governmental funds are almost certain to be insufficient if vaccines are
definitively linked to disorders with which they have been associated, including developmental
disabilities and asthma.17 Without change, the national vaccine program could confront similar
legal challenges to those that now face the housing, banking and oil drilling sectors. If such
crises occur, the public will ask how such grave unintended consequences could have been
happened.
This article argues that the absence of ordinary tort law protection in the national
childhood vaccine program, namely, the rights to informed consent and to sue manufacturers and
doctors directly, is associated with troubling facts. These facts include conflicts of interest;
inadequate safety; inadequate compensation to vaccine-injured children; inadequate vaccine
warnings; and problems in children’s health. The article argues that current vaccination
mandates abuse state police powers and violate Jacobson because they fail to require public
health necessity. It suggests that childhood vaccine mandates today are so radically different
than what Jacobson upheld that courts may be required to step in. No articles to date have made
similar claims.
Part I looks at Supreme Court decisions which authorize state compulsion of school
vaccination mandates and the legal developments before the enactment of the 1986 Law. Part II
looks at the 1986 Law and its liability and information protections for industry and medical
practitioners. Part III examines the unintended consequences of these laws. Part IV briefly
addresses ways to challenge Jacobson and amend the 1986 Law to better safeguard children.
I.
State Police Power to Compel Childhood Vaccination
A. Judicial Decisions before Jacobson v. Massachusetts
Infectious disease was a leading cause of death in the United States until the 20th century.
During the 19th century, movement from the countryside to cities, with poor housing and
inadequate sanitation and drinking water, spurred outbreaks of infectious disease.18 These
conditions resulted in repeated outbreaks of infectious disease, such as cholera, typhoid,
the credit crisis on government deregulation, explaining the relationship between the housing and mortgage crisis
and the meltdown of various financial institutions, and describing the multi-billion dollar government bailout
programs designed to keep banks from failing); See also David Barstow et al., Regulators Failed to Address Risks in
Oil Rig Fail-Safe Device, N.Y. TIMES, June 20, 2010, at http://www.nytimes.com/2010/06/21/us/21blowout.html
(describing how the Gulf oil spill could have possibly been prevented had more stringent regulations been in place
and enforced).
17
See, e.g., Carolyn Gallagher & Melody Goodman, Hepatitis B Triple Series Vaccine and Developmental
Disability in US Children Aged 1-9 Years, 90 TOXICOLOGICAL & ENVTL. CHEMISTRY 997 (2008); Kara L.
McDonald et al., Delay in Diphtheria, Pertussis, Tetanus Vaccination Is Associated With a Reduced Risk of
Childhood Asthma, 121 J. ALLERGY & CLINICAL IMMUNOLOGY 626 (2008).
18
Achievements in Public Health, 1900-1999: Control of Infectious Diseases, 48 MORBIDITY & MORTALITY WKLY.
REP. 621, 621 (1999).
4
influenza and malaria. In 1900, more than 30% of all deaths occurred among children under five
years old.19 Although vaccination carried risks, the practice became widespread in Europe and
the United States in the 1800s as a preventive health measure against smallpox, a deadly,
contagious, airborne disease.20 In the nineteenth century, vaccination against smallpox meant
introducing a milder form of the disease, cowpox, into individuals and inducing an immune
response intended to prevent the recipient from getting smallpox. If a vaccination subject
received a sufficiently strong immune response, he would not contract smallpox over several
years, even if repeatedly exposed to it.21 Compulsory smallpox vaccination was introduced in
some jurisdictions in the 1800’s to ensure 85-95% rates of vaccination in the population in order
to achieve “herd immunity,” intended to deter or prevent the spread of disease throughout the
population.22
Vaccination mandates are laws requiring individuals to be vaccinated or face penalties,
such as a fine or the loss of the right to attend public school. Before Jacobson, state statutes on
vaccination varied. In 1905, eleven states had compulsory vaccination mandates for smallpox
but the majority, thirty-four states, did not. No states had laws that forced vaccination on
unwilling subjects. In other words, no states had laws to forcibly vaccinate individuals, although
this practice reportedly did occur.23
Judicial decisions interpreting state laws on vaccination before Jacobson were similarly
diverse. In 1894, the Pennsylvania Supreme Court upheld the right of the state to exclude
unvaccinated children from school during a smallpox epidemic but took pains to point out that
the state could not physically force vaccination. It simply upheld the regulation to exclude
unvaccinated children during an epidemic for the public health.24 In 1900, the Utah Supreme
Court similarly upheld an exclusion order for an unvaccinated child, but this majority opinion
prompted a strong dissent, noting that the exclusion rule was “an attempt, indirectly, to make
vaccination compulsory” and that the medical board had no such authority.25 In 1902, the
Minnesota Supreme Court upheld a school exclusion rule for an unvaccinated child, but made
clear that its ruling was narrow and permissible “in cases of emergency only.”26 In 1900, a
California court established that no vaccination mandate could be applied in a racially
19
Id. at 621.
Jacobson, 197 U.S. at 34 (“'Smallpox is known of all to be a dangerous and contagious disease.'” (quoting
Viemeister v. White, 84 N.Y.S. 712 (N.Y. App. Div. 1903))).
21
Id.
22
Steve P. Calandrillo, Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their
Children?, 37:2 U. MICH. J.L. REFORM 353, 419-421 (2004) (describing herd immunity).
23
See e.g., Michael Willrich, “The Least Vaccinated of Any Civilized Country”: Personal Liberty and Public
Health in the Progressive Era, 20 J. POL'Y HIST. 76, 85-86 (2008) (“The local health authorities carried out the
orders during a public health emergency, and their impatience with resistance led easily to violence, including many
documented cases of physical-force vaccination.”).
24
Duffield v. Williamsport Sch. Dist., 29 A. 742 (Pa. 1894).
25
Cox v. Bd. of Educ., 60 P. 1013, 1020 (Utah 1900).
26
Freeman v. Zimmerman, 90 N.W. 783, 784 (Minn. 1902).
20
5
discriminatory manner because it would violate the equal protection clause of the 14th
Amendment to the Constitution.27
In 1903, New York’s highest court opined that the state’s mandate for school vaccination
and its state constitutional right to a public education were compatible provisions. It construed
the state constitution’s language "[t]he Legislature shall provide for the maintenance and support
of a system of free common schools, wherein all the children of this State may be educated" as a
privilege, not a right. It reasoned that because all pupils were subject to the same vaccination
obligation, the state met constitutional due process and equal protection guarantees. It further
suggested that courts owe great deference to legislatures on such questions. It relied on decisions
of several other courts that found that state constitutional guarantees of education did not
contradict vaccination mandates, even when there was no imminent threat of disease.28
While judicial decisions before Jacobson never forced vaccination, they often justified
existing mandates, whether for adults or children, and upheld exclusion of unvaccinated children
from public school during epidemics. Some courts spoke explicitly of the need to show
necessity and emergency; others took a more expansive view, leaving broad discretion to the
legislatures on matters of public health. In short, there was an emerging judicial consensus to
uphold vaccination mandates, but the overwhelming majority of states did not impose them.
And in any event, at issue was always just one vaccine against smallpox.
B. Jacobson v. Massachusetts
Unlike in 1905, today there are vaccination mandates for school admission in 50 states,29
mandates for certain categories of adults, such as healthcare workers;30 and public health
emergency acts with vaccination provisions in many states.31 Decided by the Supreme Court in
27
Wong Wai v. Williamson, 103 F. 1 (N.D. Cal. 1900).
Viemeister v. White, 84 N.Y.S. 712, 712 (N.Y. App. Div. 1903) (citing Abeel v. Clark, 24 P. 383 (Cal. 1890);
Duffield v. Williamsport Sch. Dist., 29 A. 742 (Pa. 1894); Field v. Robinson, 48 A. 873 (Pa. 1901); Bissell v.
Davison, 32 A. 348 (Conn. 1894); Blue v. Beach, 56 N.E. 89 (Ind. 1900); In re Rebenack, 62 Mo. App. 8 (Mo. Ct.
App. 1895).
29
James G. Hodge, Jr. & Lawrence O. Gostin, School Vaccination Requirements: Historical, Social, and Legal
Perspectives, 90 KY. L.J. 831, 833 (2001-02) (“Each state has school vaccination laws which require children of
appropriate age to be vaccinated for several communicable diseases.”).
30
The CDC provides information on states' requirements for healthcare workers and patients. Vaccines &
Immunizations: State Immunization Laws for Healthcare Workers and Patients, Centers for Disease Control and
Prevention (Apr. 2010), http://www2a.cdc.gov/nip/StateVaccApp/statevaccsApp/default.asp. For instance, in New
York, hospital employees must be offered Hepatitis B vaccine, and are required to be vaccinated against measles,
mumps, rubella, and influenza. Vaccines & Immunizations, Immunization Administration Requirements For State:
NY, Centers for Disease Control and Prevention (May 3, 2010), http://www2a.cdc.gov/nip/StateVaccApp/
statevaccsApp/Administration.asp?statetmp=NY.
28
31
See James G. Hodge, Jr., and Lawrence O. Gostin, The Model State Emergency Health Powers Act - A Brief
Commentary (January 2002) , http://www.publichealthlaw.net/MSEHPA/Center%20MSEHPA%20Commentary.pdf
(last visited Sept. 6, 2010).
6
1905, Jacobson has been interpreted to mean that states may impose reasonable regulations to
ensure the public health and safety, even if such regulations infringe individuals’ personal
liberty. Because of the fundamental character of this decision justifying vaccination public
health measures today, the article examines the decision in detail.
Jacobson came to the Supreme Court from the Massachusetts Supreme Court, which
upheld the validity of a Cambridge, Massachusetts mandate to compel smallpox vaccination for
all adults on penalty of a $5 fine (the equivalent of about $110 today).32 Mr. Jacobson refused to
comply with the regulation and would neither agree to be vaccinated nor pay the $5 fine. Mr.
Jacobson argued that the regulation violated his rights under the 5th and 14th Amendments.33 He
argued that the state mandate threatened his life, liberty and property and deprived him of the
due process and equal protection of the law. In essence, he argued that his right to bodily
integrity and personal liberty trumped the state’s right to impose a vaccination in the name of
public health.
In upholding the Cambridge regulation, the Supreme Court reasoned that constitutional
protection of individuals is not unlimited and that states retain police powers to ensure public
health and safety. The Court argued that states retain the right to issue reasonable regulations
and that in the context of a smallpox epidemic, Cambridge’s ordinance was not “unreasonable,
arbitrary or oppressive.”34 The Court argued that it was the legitimate province of the legislature
to decide what measures would be best, and that the legislature was unquestionably aware of
opposing views about vaccination among the medical profession and the electorate. The Court
pointed out that the regulation required the inhabitants to be vaccinated only when “that was
necessary for the public health or the public safety.”35 The Court found that the regulation did
not violate the 14th Amendment because it was “applicable equally to all in like condition.”36 The
Court analogized the state’s police power to impose a vaccination mandate to its power to
enforce quarantines and to the federal government’s right to impose a military draft.37
Contemporary public health discourse commemorates the first part of the decision but
often fails to note the second. The second half describes what would constitute potential abuse
of the police power. The Court did not give states blind deference. The Court justified the
Cambridge regulation as reasonable, imposing one vaccine, on an emergency basis, on the entire
adult population, in the context of a contagious, deadly epidemic, with a relatively small fine for
32
The Consumer Price Index was started in 1913 to track changes in prices of consumer goods. A government
inflation calculator indicates that $5 in 1913 would be the same as about $110.11 in 2010. Bureau of Labor
Statistics: CPI Inflation Calculator, http://www.bls.gov/data/inflation_calculator.htm.
33
“No state shall make nor enforce any law abridging the privileges or immunities of citizens of the United States
nor deprive any person of life, liberty or property without due process of law, nor deny to any person within its
jurisdiction the equal protection of the laws.” U.S. CONST. amend. XIV, § 1.
34
Jacobson, 197 U.S. at 27.
35
Id.
36
Id.
37
Id. at 29-30.
7
non-compliance. The Court’s paradigm was clear: a mandate in “an emergency;”38 when there
was “imminent danger;”39 when “an epidemic of disease…threatens the safety of [society’s]
members;”40 when there was “the pressure of great dangers”41 and an “epidemic that imperiled
an entire population.”42
Describing potential abuse of police power, the Court opined:
[a regulation] might be exercised in particular circumstances and in reference to
particular persons in such an arbitrary, unreasonable manner, or might go so far
beyond what was reasonably required for the safety of the public, as to authorize
or compel the courts to interfere for the protection of such persons.43
The Court noted cases when state laws “went beyond the necessity of the case, and, under the
guise of exerting a police power…violated rights secured by the Constitution.”44 The Court
noted:
there is, of course, a sphere within which the individual may assert the supremacy
of his own will, and rightfully dispute the authority of any human government,
especially of any free government existing under a written constitution, to
interfere with the exercise of that will.45
The Court cautioned that if a state statute purported to have been enacted for the public
health, but “has no real or substantial relation to those objects, or is, beyond all question, a plain,
palpable invasion of rights secured by the fundamental law, it is the duty of the court to so
adjudge.”46 The Court anticipated the possibility that the police power to vaccinate might be
exerted in circumstances when regulations could be “so arbitrary and oppressive…as to justify
the interference of the courts to prevent wrong and oppression.”47
The Court expressly created a medical exemption from vaccination, when a person was
not a fit subject for vaccination and it “would be cruel and inhuman in the last degree” to
vaccinate him.48 Because of Jacobson, medical exemptions exist in all 50 states.49 The Court
38
Id.
Id at 29.
40
Id. at 27.
41
Id. at 28.
42
Id. at 31.
43
Id. at 28 (citing Wis., Minn., & Pac. R.R. v. Jacobson, 179 U.S. 287 (1900)).
44
Id.
45
Id at 29.
46
Id. at 31.
47
Id. at 38.
48
Id at 39.
49
Hodge & Gostin, supra note 29 at 874 (“While the statutory provisions vary from state to state, all school
immunization laws grant exemptions to children with medical contra-indications to immunization, consistent with
39
8
also specifically approved that the statute granted special medical exemption to children. It
wrote that “there are obviously reasons why regulations may be appropriate for adults which
could not be safely applied to persons of tender years.”50 In other words, it approved the
Massachusetts regulation which granted infants and children greater protection from compulsion
than adults.
Although the Court was clearly wary of treading in areas of legislative competence, it
proclaimed the right, indeed the responsibility, to give sensible construction to any regulation so
that it would not lead to “injustice, oppression, or an absurd consequence.”51 It made clear that
no law should be interpreted in practice to be “cruel and inhuman in the last degree.”52
While subsequent courts have interpreted Jacobson to justify regulations beyond
necessity to prevent potential disease, Jacobson itself sounded the alarm that courts should be
vigilant to examine and thwart unreasonable assertions of state power.
C. Jacobson’s Application
Initial application of Jacobson was circumspect. From 1907 to 1914, state appellate and
supreme courts construed Jacobson as permitting single vaccination mandates during smallpox
outbreaks.53 The courts upheld mandates and exclusion of unvaccinated school children during
emergencies. These decisions applied the “arbitrary, unreasonable and oppressive” standard and
looked for evidence of public necessity, and particularly the threat of epidemic.54 These
decisions found that statutes that did not include medical exemptions had to be read to contain
them.55 The decisions required that school boards act in good faith and exclude unvaccinated
students only as long as the danger of smallpox endured.56
Beginning in 1916, however, judicial interpretations of Jacobson started to broaden. The
Alabama Supreme Court read into Jacobson the implied power to prevent epidemics, not simply
to respond to existing ones. A father sued the school board for excluding his unvaccinated
daughter from school when there was no smallpox epidemic.57 The court upheld the state’s
delegation of authority to the school board and the state’s right to prevent disease. The decision
also argued that mandates of children and not adults – the opposite of the mandate in question in
the judicial and ethical principles of harm avoidance asserted by the Supreme Court in Jacobson v.
Massachusetts.”).
50
Jacobson, 197 U.S. at 30.
51
Id. at 39.
52
Id.
53
Hammond v. Inhabitants of Hyde Park, 80 N.E. 650 (Mass. 1907); O’Bannon v. Cole, 119 S.W. 424 (Mo. 1909);
McFadden v. Shorrock, 104 P. 214 (Wash. 1909); McSween v. Bd. of Sch. Trs., 129 S.W. 206 (Tex. 1910); People
v. Ekerold, 105 N.E. 670 (N.Y. 1914).
54
O’Bannon, 119 S.W. at 427.
55
McFadden, 104 P. at 216.
56
Hammond, 80 N.E. at 651.
57
Herbert v. Bd. of Educ., 73 So. 321 (Ala. 1916).
9
Jacobson – were valid because groups of children “constitute[e] a condition different, with
respect to hygienic circumstances, effects, and results, from that to be found in any other
character of assemblage in a municipality.”58 The court deferred to municipal authorities on
public health.59
The Kentucky Supreme Court reached a similar conclusion, finding that boards “are not
required to wait until an epidemic actually exists before taking action. Indeed, one of the chief
purposes of their existence is to adopt and enforce such timely measures as will prevent
epidemics.”60 These decisions interpreted Jacobson broadly; in neither situation was there an
imminent danger or necessity for the state to act in self-defense. While these decisions
authorized preventive measures, they did not impose insurmountable burdens: they imposed one
vaccine when smallpox was still in circulation.
1. Zucht v. King: Applying Jacobson to School Mandates
In 1922, the Supreme Court held in Zucht v. King that a smallpox vaccination mandate
for school admission was a valid exercise of the police power.61 In a cursory, unanimous
decision, the Court cited to Jacobson as settling that compulsory vaccination may be a
requirement of public school admission.62 The Court denied the petitioner’s claim of
infringement of her 5th and 14th Amendment rights based on Jacobson.63 It considered, though,
that the law might have been administered in a way that violated her rights.64 Nonetheless, the
Court found that the school vaccination mandate had not conferred arbitrary power but “only that
broad discretion required for the protection of the public health.”65 The Court did not inquire into
the circumstances of the epidemic and affirmed substantial deference to school boards, with
smallpox as the relevant, but unnamed, backdrop.
Zucht did not alter Jacobson’s fundamental analysis that necessity is required to justify
state police powers – it simply applied this analysis to schools specifically. Whether because the
Justices thought that Jacobson’s analysis was sufficient, or because smallpox posed an obvious
risk, the Supreme Court affirmed the mandate without detailed discussion. Indeed, Zucht is a
three paragraph decision presumably intended to stop judicial challenges to school smallpox
vaccination mandates. But Zucht did shift Jacobson’s paradigm somewhat, by upholding a
mandate exclusively for children and not for the entire population. Still, Zucht did not lower
Jacobson’s threshold of necessity to compel vaccination.
58
59
60
61
62
63
64
65
Id. at 323.
Id.
Bd. of Trs. v. McMurtry, 184 S.W. 390, 394 (Ky. 1916).
Zucht, 260 U.S. at 176.
Id. at 176.
Id.
Id. at 177.
Id.
10
2. Early Interpretation of Jacobson
In the early 1900’s, several courts rejected expansive interpretations of Jacobson. Courts
did not universally approve of legislatures’ broad discretion to require vaccination mandates
outside of emergencies. In 1919, the Supreme Court of North Dakota struck down a school
mandate to exclude unvaccinated children when there was no imminent threat.66 This court
decided that boards of health “cannot promulgate and enforce rules which merely have a
tendency [to prevent disease]…but which are not founded upon any existing condition or danger
reasonably to be apprehended.”67
A concurrence in this North Dakota case went farther, arguing that “child vaccination in a
state where smallpox does not prevail…has no excuse; it is a barbarism.” 68 The concurrence
focused on the responsibility of courts to protect civil liberties from abuses of state power and
warned against judges “too ready to follow the example of Pontius Pilate – to wash their hands –
and to blame a supposed law or a precedent for their unjust decisions.”69 The judge noted the
central roles of better sanitation, clean water and nutrition in public health and the self-interest of
the medical profession and manufacturers in vaccination mandates. He noted, in 1919, the
potential for conflicts of interest:
Of course a different story [than the story about vaccine risks] is told by the class
that reap a golden harvest from vaccination and the diseases caused by it. Yet,
because of their self-interest, their doctrine must be received with the greatest care
and scrutiny. Every person of common sense and observation must know that it is
not the welfare of the children that causes the vaccinators to preach their doctrines
and to incur the expense of lobbying for vaccination statutes.…And if anyone
says to the contrary, he either does not know the facts, or he has no regard for the
truth.70
But his cautionary view was not the predominant one.
The dominant trend adopted an expansive reading of state police powers for public
health. In 1923, in a Texas decision, the court’s majority disallowed the medical vaccination
certificate of a child who had been immunized using a homeopathic technique. The court cited
to Jacobson for the proposition that health boards may dictate the method as well as the
requirement of vaccination as a legitimate restraint on liberty.71 This Texas court majority
66
67
68
69
70
71
Rhea v. Bd. of Educ., 171 N.W. 103 (N.D. 1919).
Id. at 106.
Id. at 107 (Birdzell, J., concurring).
Id. at 108.
Rhea, 171 N.W. at 107 (Birdzell, J., concurring).
Abney v. Fox, 250 S.W. 210 (Tex. App. 1923).
11
decision prompted a strong dissent, arguing that “necessity is the source of the authority to
require vaccination, and no such authority exists where it is conceded that no such necessity
exists.”72 The dissent cited to Jacobson’s cautionary language.
3. Later Interpretation of Jacobson
By 1934, courts read Jacobson to validate preventive smallpox mandates.73 The
Mississippi Supreme Court granted discretion to public health authorities, stating “the
presumption is in favor of the reasonableness and propriety of regulations enacted in pursuance
of such grant of power.”74 A 1934 Texas case decided that it could not evaluate whether an
emergency existed.75 Rather, it held “we cannot attempt to measure how pressing a necessity
must be in order to allow the board’s discretion to be exercised.”76 That court flatly rejected the
idea that the court could assess emergency.77
Courts increasingly abdicated the role to assess the reasonableness of the state’s exercise
of police powers. For instance, the New Jersey Supreme Court, in upholding a vaccination
mandate, held that “the question of the desirability or efficacy of compulsory vaccination...and
whether it is wise or unwise is strictly a legislative and not a judicial question.”78 The Court read
Jacobson to justify all vaccination mandates, disregarding its language to reject unreasonable,
arbitrary or oppressive state actions.79
A 1951 Arkansas case, asked to evaluate the validity of a preventive vaccination
mandate, decided that it was not the court’s place to judge the efficacy or safety of
vaccinations.80 The court even suggested that the plaintiffs lodge objections with the Board of
Health rather than the court.81
By the mid-1950’s, it was arguably a settled interpretation of law that vaccination
mandates were presumptively valid, regardless of emergency. Jacobson’s robust cautionary
language had been all but erased from the precedent’s application. In 1964, the Arkansas
Supreme Court held that parents had no legal right to refuse vaccination of their children. The
court removed children from the father’s custody, placed them with a guardian, and ordered them
to be forcibly vaccinated.82 The Arkansas court did not recognize the validity of the children’s
religious exemptions, and in referring to Jacobson, reasoned that “it is within the police power of
72
73
74
75
76
77
78
79
80
81
82
Id. at 214 (Key, C.J., dissenting).
Hartman v. May, 151 So. 737 (Miss. 1934).
Id. at 739.
Booth v. Bd. of Educ., 70 S.W.2d 350 (Tex. Civ. App. 1934).
Id. at 353.
Id.
Sadlock v. Bd. of Educ., 58 A.2d 218, 220 (N.J. 1948).
Id.
Seubold v. Fort Smith Special Sch. Dist., 237 S.W.2d 884, 887 (Ark. 1951).
Id.
Cude v. State, 377 S.W.2d 816 (Ark. 1964).
12
the State to require that school children be vaccinated against smallpox....In fact, this principle is
so firmly settled that no extensive discussion is required.”83 The Arkansas Supreme Court
upheld the prosecutor’s charge of child neglect against the father who refused to vaccinate his
children on religious grounds.
Jacobson does not justify forced vaccination of adults or children. Indeed, by contrast,
Jacobson upheld the validity of a monetary penalty on an adult for non-compliance. Jacobson
does not justify a forced medical intervention that could, depending on individual constitution,
lead to a result “cruel and inhuman in the last degree.”84 On the contrary, Jacobson, by
upholding a fine for non-compliance, implied that to force vaccination would be in “a sphere
within which the individual may assert the supremacy of his own will, and rightfully dispute the
authority of any human government, especially of any free government existing under a written
constitution, to interfere with the exercise of that will.”85
Potential plaintiffs have elected not to challenge Jacobson directly over many decades,
perhaps because of overbroad judicial interpretation and extreme deference to states for
preventive school vaccination.86 Given courts’ deference to legislatures and agencies, potential
plaintiffs opposing vaccination mandates presumably considered direct challenges futile.
Instead, since the 1960’s when states began to compel children to receive six or more vaccines in
multiple doses, litigation has centered on exemptions. Forty-eight of the fifty states provide for
religious exemption from vaccination mandates.87 Cases before courts have considered whether
membership in an unrecognized faith justifies religious exemption;88 whether exclusion of
unvaccinated children from school following a measles outbreak is justified;89 whether a parent’s
religious objections to vaccination are sincerely held;90 whether religious exemptions violate the
First Amendment establishment clause;91 and whether state law with no religious exemption
violates the First, Fifth and Fourteenth Amendments.92
Since the 1960’s, states have sometimes punished non-compliant parents harshly. Even
when religious exemptions exist, courts have sometimes found parents liable for child neglect
83
Id. at 819.
Jacobson, supra note 9.
85
Jacobson, supra note 9.
86
See ROBERT D. JOHNSTON, THE RADICAL MIDDLE CLASS: POPULIST DEMOCRACY AND THE QUESTION OF
CAPITALISM IN PROGRESSIVE ERA PORTLAND, OREGON PAGE (2003); see also Willrich, supra note 23.
87
See, e.g., States With Religious and Philosophical Exemptions from School Immunization Requirements,
National Conference of State Legislatures (June 2010),
http://www.ncsl.org/IssuesResearch/Health/SchoolImmunization ExemptionLaws/tabid/14376/Default.aspx; Hodge
& Gostin, supra note 29, at 44, n.233.
88
Brown v. Stone, 378 So.2d 218 (Miss. 1979).
89
Maricopa County Health Dept. v. Harmon, 750 P.2d 1364 (Az. Ct. App. 1987).
90
LePage v. State, 18 P.3d 1177 (Wyo. 2001).
91
McCarthy v. Boozman, 212 F. Supp. 2d 945 (E.D. Ark. 2002); Boone v. Boozman, 217 F. Supp. 2d 938 (E.D.
Ark. 2002).
92
Workman v. Mingo County Schs., 667 F. Supp. 2d 679 (S.D.W.Va. 2009).
84
13
when they refuse to vaccinate their children.93 Courts have mandated child removal and forced
vaccination of children in families who have asserted religious objections.94
Current interpretations of Jacobson justify results Jacobson did not: multiple preventive
vaccination mandates exclusively for children, in the absence of public health emergencies and
extreme penalties for non-compliance. Punishments include loss of education, social isolation,
parents’ loss of custodial rights, child neglect sanctions against parents, and even forced
vaccination. In Jacobson and Zucht, the Supreme Court upheld mandates with one vaccine
during public epidemics. States and courts have moved far from the original Jacobson
precedent.
D. Scholarly Interpretation of Jacobson
The one hundredth anniversary of Jacobson in 2005 prompted a retrospective on the
decision’s continuing impact in the American Journal of Public Health, the leading journal for
public health.95 The contributors applauded the decision for providing a set of legal balancing
tests for public health decisions. Professor Gostin, a prominent expert on public health and
vaccination law asked, “Would Jacobson be decided the same way if it were presented to the
Court today?” He answered, “indisputably yes, even if the style and the reasoning would
differ.”96
Professors Mariner, Annas and Glantz took a different view, arguing that a mandatory
vaccination mandate today “to prevent dangerous contagious diseases in the absence of an
epidemic” would probably be upheld “as long as (1) the disease still exists in the population
where it can spread and cause serious injury to those infected, and (2) a safe and effective
vaccine could prevent transmission to others.”97 In their view,
Public health programs that are based on force are a relic of the 19th century; 21st
century public health depends on good science, good communication, and trust in
public health officials to tell the truth. In each of these spheres, constitutional
rights are the ally rather than the enemy of public health. Preserving the public’s
health in the 21st century requires preserving respect for personal liberty.98
93
In re Elwell, 284 N.Y.S.2d 924 (N.Y. Fam. Ct. 1967); In re Christine M., 595 N.Y.S.2d 606 (N.Y. Fam. Ct.
1992).
94
Cude, 377 S.W.2d at 821.
95
James Colgrove & Ronald Bayer, Manifold Restraints: Liberty, Public Health, and the Legacy of Jacobson v.
Massachusetts, 95 AM. J. PUB. HEALTH 571 (2005); Lawrence O. Gostin, Jacobson v. Massachusetts at 100 Years:
Police Power and Civil Liberties in Tension, 95 AM. J. PUB. HEALTH 576 (2005); Wendy K. Mariner et al., Jacobson
v. Massachusetts: It's Not Your Great-Great-Grandfather's Public Health Law, 95 AM. J. PUB. HEALTH 581 (2005).
96
Id., Gostin, at 580.
97
Mariner et. al., supra note 95, at 586.
98
Id. at 588.
14
While acknowledging the benefits of voluntary compliance and respect for human rights,
a third essay argued that Jacobson accurately reflected the real trade-offs that may be necessary
between individual rights and public health. Professors Colgrove and Bayer suggested that
Jacobson appropriately confronted the tensions between the state and the individual, and that
only through such a confrontation “can a clear understanding about the potential costs of public
health policy emerge.”99 These retrospectives contemplated mandates for the whole population,
however, and not how Jacobson is applied – almost exclusively on children through compulsory
vaccination for school.
On the issue of school vaccination mandates, most scholars today praise mandates and
attribute to them the near eradication of childhood infectious diseases, without consideration of
other factors, such as sanitation, hygiene, nutrition and the availability of other medical
interventions, such as antibiotics.100 They express grave concerns about exemptions from
vaccination mandates that might diminish herd immunity. Many argue that there should be no
religious exemptions to vaccination mandates101 and that all non-medical exemptions should be
contingent on state discretion.102 Unlike this author, most commentators do not perceive in
today’s childhood vaccination program the dangers to which Jacobson alluded.
E. Legal Developments Leading to the 1986 Law
Vaccination mandates became legally well-entrenched when there was only one and
when smallpox was a life-threatening, contagious disease. By the 1950’s, when the polio
vaccine became available, health officials opted for persuasion rather than compulsion to achieve
compliance. Only a minority of states passed polio mandates. The National Foundation for
99
Colgrove & Bayer, supra note 95, at 575.
Daniel A. Salmon et. al., Compulsory vaccination and conscientious or philosophical exemptions: past, present,
and future, 367 LANCET 436 (2006) (“Vaccination is one of the greatest achievements in medicine and public health:
wild-type poliovirus will soon be eradicated and each year, about 5 million life-years are saved by control of
poliomyelitis, measles, and tetanus.”); Hodge & Gostin, supra note 29, at 875 (“The incidence of common
childhood illnesses (such as measles, pertussis, mumps, rubella, diphtheria, tetanus, and polio) which once
accounted for a substantial proportion of childhood morbidity and mortality has significantly declined since the
advent and use of vaccines.”); Calandrillo, supra note 22 at 353 (“Vaccinations against life-threatening diseases are
one of the greatest public health achievements in history. Literally millions of premature deaths have been
prevented, and countless more children have been saved from disfiguring illness.”).
101
See, e.g., Calandrillo, supra note 22, at 429 (“The AMA has already gone on record indicating its opposition
to both religious and philosophical exemptions to vaccination – states might consider doing the same.”).
102
Melinda Wharton et. al., Concurrent Session: A. Applying Law Throughout the Life Stage: Childhood
Immunizations: Exemptions and Vaccine Safety, 33 J.L. MED. & ETHICS 34 (2005) (“Based on these principles, a
nonmedical vaccination exemption has been proposed that requires a firmly held, bonafide belief; proof of health
department-approved vaccine counseling; signed personal statement by the parent; department discretion to reject
based on individual and community risk; annual renewal; and ongoing central exemption tracking” (emphasis
added) (citing Daniel A. Salmon et. al., Public Health and the Politics of School Immunization Requirements, 95
AM. J. PUB. HEALTH 778 (2005))).
100
15
Infantile Paralysis, the non-profit organization that helped develop and distribute the polio
vaccine, opposed compulsion on principle.103
But fundamental changes in vaccination mandates occurred in the late 1960’s. In 1968,
half the states had laws requiring one or more vaccinations for school. By 1981, all 50 states had
required school vaccines for measles and most other vaccine-preventable childhood diseases.104
In the 1960’s, mandates served more of a public education role more than a legal one.105
But state coercion soon became real.

The Advisory Committee on Immunization Practices (ACIP)
Although Jacobson remained the landmark case on state compulsory vaccination, the
federal government began to assume the driving role in immunization policy. Government
experts within the Centers for Disease Control and Prevention adopted the goal of eradicating
infectious disease.106 The federal government established an infrastructure for a war on
infectious disease. In 1964, the Advisory Committee on Immunization Practices (ACIP) first
met.107 This organization, under the Public Health Service Act,108 was created to “assist
states…in the prevention and control of communicable diseases; to advise states on matters
relating to the preservation and improvement of the public’s health; and to make grants to states
to assist in meeting the costs of communicable disease control programs.”109
ACIP’s charter requires it to advise about vaccines against vaccine-preventable diseases
for use by the public.110 For children, the charter requires ACIP to create a list of vaccines for
federal subsidy.111 ACIP became the only federal entity to make vaccination recommendations
103
Colgrove & Bayer, supra note 95, at 573 (“Senior managers with the National Foundation for Infantile Paralysis,
the charitable organization that was instrumental in developing and distributing the vaccine, believed that
compulsory laws were wrong in principle.”).
104
Id.
105
Id. ([T]he laws served as a ‘means of bringing to individuals’ attention to the continuing publicly perceived need
for immunization.”)
106
See, e.g., JAMES COLGROVE, STATE OF IMMUNITY: THE POLITICS OF VACCINATION IN TWENTIETH-CENTURY
AMERICA 212 (2006) (“In the 1960s, the elusive dream of utterly eliminating one or more infectious diseases came
closer to being a reality than ever before, and a spirit of 'eradicationism' took center stage in vaccination policy....
The Communicable Disease Center launched a national campaign to eradicate measles in the fall of 1966.”)
107
CDC: Vaccines Timeline: Fifty Years of Vaccine Progress (Oct. 19, 2006), http://www.cdc.gov/vaccines/pubs/
vacc-timeline.htm.
108
42 U.S.C.S. § 217a (2010) (“The Secretary may...appoint such advisory councils or committees... for the purpose
of advising him in connection with any of his functions.”); see also ACIP Charter: Authority, Objective, and
Description, Authority (Apr. 6, 2010), http://www.cdc.gov/vaccines/recs/acip/ charter.htm.
109
Id. at Objective and Scope of Activities.
110
Id. at Description of Duties. (“provide advice and guidance…regarding the most appropriate selection of
vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population”)
111
Id.
16
to the states for public health, and for children in particular.112 States today rely on ACIP’s
recommendations for school vaccination mandates. The federal government subsidizes vaccines
on the ACIP-recommended list for indigent children,113 and manufacturers receive liability
protection for ACIP-recommended vaccines under the 1986 Law.114
ACIP meets several times each year and consists of fifteen non-governmental expert
advisors whom the HHS Secretary appoints.115 In addition to fifteen voting members, ACIP
includes eight ex officio members who represent federal agencies with responsibility for
immunization programs and twenty-six non-voting representatives of liaison organizations.116
Under its charter, ACIP must have at least one citizen representative -- all the rest may be from
public health and medical specialties.117 In other words, of the forty-nine people charged to
deliberate on national vaccine policy, only one must represent the public.
At ACIP’s inception, Jacobson’s requirements and the federal government’s mission for
immunization headed in two potentially different directions. Jacobson justified state and local
health officials to mandate vaccines against contagious epidemics that posed an “imminent
danger” to the “entire population.”118 By contrast, ACIP, the new driver of national
immunization policy, aimed to prevent and control infectious disease and to fund state childhood
vaccination programs with no reference to necessity.119 ACIP’s mission does not reference
Jacobson’s requirements of emergency, self-defense, imminent danger or local authorities’
discretion to fight against disease. Instead, the federal government in ACIP created an
infrastructure to prevent and control communicable diseases particularly among children through
compulsory vaccination. By 1981, all states made vaccination against most vaccine-preventable
diseases mandatory for school attendance.120

Vaccine Injury Litigation
With more compelled vaccination came more reported vaccine injuries and lawsuits.
Plaintiffs brought lawsuits for vaccine injury based on negligence, strict liability and
manufacturers’ failure to warn of known risks. Although parents did not have the choice to
refuse vaccination for children to attend school, except for limited exceptions, they had two tort
law protections: the right to accurate warnings and the right to sue manufacturers.
112
Id. (“establish…review and, as appropriate, revise a list of vaccines for administration to children and
adolescents eligible to receive vaccines through the Vaccines for Children Program….”)
113
Id.
114
42 U.S.C. 300aa-6 (2010) (authorizing appropriations necessary to carry out the statute's provisions) and
§ 300aa-11 (providing liability protection for manufacturers of vaccines).
115
ACIP Charter, supra note 108, at Meetings, Duration, and Termination: Estimated Number and Frequency of
Meetings; Id. at Membership, Subcommittees, and Recordkeeping: Membership and Designation.
116
ACIP Charter, supra note 108, at Membership, Subcommittees, and Recordkeeping.
117
Id.
118
Jacobson, 197 U.S. at 29.
119
ACIP Charter, supra note 108, at Authority, Objective, and Description: Objective and Scope of Activities.
120
COLGROVE, supra note 106 at 177.
17
In two publicized cases, petitioners won lawsuits against vaccine manufacturer Wyeth on
failure to warn claims. Both plaintiffs suffered permanent disabilities from the oral polio
vaccine. In Davis v. Wyeth, an adult contracted polio from the oral polio vaccine and argued in
1968 that he had not been warned of this potential risk.121 In Reyes v. Wyeth, a child contracted
polio after receiving the vaccine and argued in 1970 that she had received no warning from the
nurse who vaccinated her.122 The Reyes Court rejected the argument that the manufacturer had
no duty to warn.123
By the 1980’s, 250 damage claims against manufacturers for vaccine injury were filed
each year.124 Some vaccine manufacturers left the marketplace and others threatened to do so
because of tort liability.125 Vaccine manufacturers raised the price of vaccines, passing on to
consumers the costs of litigation.126
In 1965, one year after its inception, ACIP urged the creation of a federal program to
compensate victims out of government funds and to relieve manufacturers of ordinary tort
liability.127 ACIP recommended that this would keep the vaccine market stable, keep vaccines
affordable and ensure compensation to victims. In part because of the Davis and Reyes
decisions, manufacturers and medical communities joined this recommendation.128 Later, the
American Academy of Pediatrics developed detailed proposals for a compensation scheme that
would also relieve doctors of tort liability.129 And indeed, other developed countries had already
adopted governmental compensation schemes for vaccine injury compensation in the 1970’s and
1980’s.130
In another important legal development, scholars and practitioners adopted the Second
Restatement of Torts in 1965. As a compilation of tort law and practice, the Second Restatement
influenced many state tort laws, particularly in product liability. The Restatement characterized
vaccines as “unavoidably unsafe products.”131 The Restatement provides:
There are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs. An outstanding example is the vaccine
for the Pasteur treatment of rabies, which not uncommonly leads to very serious
121
122
123
124
125
126
127
128
129
130
131
Davis v. Wyeth, 399 F.2d 121 (9th Cir. 1968).
Reyes v. Wyeth, 498 F.2d 1264 (5th Cir. 1974).
Id. at 1293; see COLGROVE, supra note 106, at 189.
COLGROVE, supra note 106, at 212.
Id. at 190, 213.
Id. at 212.
Id. at 192.
Id. at 193.
Id. at 208.
Id. at 193.
Restatement (Second) of Torts § 402A cmt. k (1965).
18
and damaging consequences when it is injected….Such a product, properly
prepared, and accompanied by proper directions and warning, is not defective, nor
is it unreasonably dangerous.132
The Restatement noted that a person infected with rabies would likely be willing to accept the
risk of an “unavoidably unsafe” vaccine because the alternative was imminent death.133
The 1976 swine flu epidemic also played an important role in laying the groundwork for
the U.S. compensation scheme that became the 1986 Law. Based on fears of a repeated 1918 flu
epidemic, Congress granted vaccine manufacturers liability protection for swine flu vaccines that
manufacturers prepared in haste.134 While the 1976 flu was mild, there were several reports of
cardiac arrest and hundreds of cases of a paralytic disorder, Guillain-Barre syndrome, as adverse
effects from the vaccines.135 The program was suspended in 1976 and widely viewed as a
failure.136
The swine flu episode nonetheless focused public attention on vaccines and the need to
provide injury compensation. In 1976-77, the Department of Health, Education and Welfare
convened working groups to prepare recommendations. A high profile committee, the
Department of Health, Education, and Welfare's committee on informed consent, recommended
that voluntary vaccination programs were preferable to mandatory ones.137 Some advisors, a
minority, recommended that “compulsory vaccination was acceptable only in cases where the
unvaccinated posed an imminent danger of spreading disease to others.”138 Implicitly drawing
on Jacobson and John Stuart Mill’s utilitarian harm avoidance principle, they argued that people
should not be forced to vaccinate simply for their own or the public’s good.139 This group
advocated that the national advisory council on vaccination should have a majority or substantial
representation of lay citizens.140
Despite calls for a compensation system and the swine flu compensation program, the
status quo of vaccine tort litigation continued through the mid-1980’s. A 1982 vaccine injury
prompted the Supreme Court of Nevada’s 1994 decision, highlighting the problems of lack of
informed consent under compulsory vaccination mandates.141 In Allison v. Merck, a mother took
132
Id.
Id.
134
COLGROVE, supra note 106, at 194.
135
Id.
136
Id. at 194-95.
137
Id. at 195-96.
138
Id. at 196.
139
Id.
140
Id. at 197, n.41, citing to “Report and Recommendations, National Immunization Work Group on Consent,” in
Reports and Recommendations of the National Immunization Work Groups, JRB Associates, Mar. 15, 1977 at C 3-4
(A National Immunization Policy Council should have “representatives of the public who are not involved in the
production of vaccines or the conduct of the immunization programs. [This group] either should constitute the
majority of the Council’s membership or should be substantially represented in the membership of the Council.”)
141
Allison v. Merck, 878 P.2d 948 (Nev. 1994).
133
19
her seventeen-month old child to receive a measles, mumps and rubella vaccine.142 The child
contracted encephalitis from the vaccine, leading to blindness, deafness, mental retardation and
seizures.143 The Supreme Court of Nevada recognized the mother’s right to bring strict liability
and failure to warn claims before a jury.144
The Allison Court disagreed with the Second Restatement of Torts’ interpretation of
vaccines’ “unreasonably dangerous” nature. The Court explained that what frees the
manufacturer of the rabies vaccine in comment k of the Restatement from liability is not the
“unreasonably dangerous” nature of the vaccine, but that the rabies victim chooses to be injected
with a vaccine known to have “damaging consequences” rather than likely die from rabies.145 “It
is the voluntary choice…that eliminates tort liability,” not the “unavoidably unsafe” nature of the
product.146
The Court pointed out that the mother of the vaccine-injured child “never had any real
choice” about vaccinating her son.147
[S]he was faced with the Hobson’s choice of either having the vaccine
administered or not having the privilege of sending her son to private or public
school. Choosing not to have her son attend school, of course, would have
subjected her to criminal penalties unless she had the means to have her son
educated at home….[I]t is hard to conclude that [the Allisons] freely accepted the
risk of the horrible injuries resulting in this case.148
The Court found fault with the CDC’s warning that accompanied the Merck vaccine and
held that a jury could reasonably conclude that the warning was insufficient.149 It noted that the
CDC’s warning -- “[a]lthough experts are not sure, there might be a very remote possibility – a
chance in a million – that takers of the vaccine may have a more serious reaction, such as
inflammation of the brain (encephalitis)”150 -- did not state that the vaccine could lead to
blindness, deafness and mental retardation, as the manufacturer and the government knew were
possible.151 Overturning decisions below, the Court concluded that the petitioners were free to
pursue actions for strict liability and duty to warn at trial and remanded the case.152
142
143
144
145
146
147
148
149
150
151
152
Id. at 951.
Id.
Id. at 952.
Id. at 954.
Id.
Id.
Id.
Id. at 957.
Id. (internal quotations omitted).
Id. at 958.
Id. at 961.
20
From the 1960’s until the 1986 Law took effect, courts decided cases on informed
consent and the manufacturer’s duty to warn inconsistently, both allowing plaintiffs to put their
claims before juries and dismissing their suits before trial.153 Some cases received big
settlements and awards and most received no compensation. In part to address this inconsistency
in compensation, Congress passed the 1986 Law.
II.
The 1986 Law
Congress enacted the 1986 Law almost two decades after the ACIP first recommended a
government compensation scheme. Congress held hearings over many years, including
testimony from the pharmaceutical industry, doctors, and parents of vaccine-injured children.
Through the Law, Congress sought to achieve several objectives: (1) to create the infrastructure
for a national immunization program;154 (2) to insulate industry and the medical profession from
liability;155 (3) to establish a program to compensate the injured;156 and (4) to promote safer
vaccines.157
The Law outlined an ambitious agenda of research, production, procurement, distribution,
promotion and purchase of vaccines.158 It established the National Vaccine Injury Compensation
Program (VICP) for “vaccine-related injury or death.”159 In its legislative history, Congress
made clear that compensation was to be swift, generous and non-adversarial.160 Congress
enacted the statute to compensate children who were injured while serving the public good.161
The Program requires the parents of vaccine-injured children to file first in the VICP
before in any other court.162 The Court of Federal Claims in Washington, D.C. administers it.163
After filing in the VICP, however, petitioners retain the right to go to civil court after rejecting a
VICP decision or waiting a specified period.164 Congress intended to create an administrative
program, where families would establish injuries specified in the Vaccine Injury Table and
receive compensation.165
153
See, e.g., Mazur v. Merck, 964 F.2d 1348 (3rd Cir. 1992) (affirming summary judgment in favor of appellee
drug manufacturer).
154
42 U.S.C. § 300aa-2.
155
Id. § 300aa-11.
156
Id. § 300aa-10.
157
Id. § 300aa-27.
158
Id. § 300aa-2.
159
Id. § 300aa-10.
160
Brief of Vaccine Injured Petitioners Bar Association et al. as Amici Curiae in Support of Petitioners, Bruesewitz
v. Wyeth, Inc., No. 09-152 (filed June 1, 2010) [hereinafter Brief of Vaccine Injured Petitioners Bar Association]
(citing H.R. REP. NO. 99-908, pt. 1, reprinted in 1986 U.S.C.C.A.N. 6344).
H.R. Rep. 99-908 (1986), reprinted in U.S.C.C.A.N. 6344.
161
Id.
162
Id. § 300aa-11.
163
Id. § 300aa-12.
164
Id. § 300aa-21.
165
Id. § 300aa-14; see current Vaccine Injury Table at http://www.hrsa.gov/vaccinecompensation/table.htm.
21
When Congress passed the Law, there were many recognized vaccine injuries, including
anaphylaxis, encephalopathy, paralytic polio, chronic arthritis, and other acute complications,
including death.166 Almost all injuries on the Vaccine Injury Table were to have occurred within
30 days. Most were to have occurred within hours or days of the vaccine.167 If petitioners met
the precise requirements of the specified injuries, then they would not be required to litigate and
would have a presumption of compensation.168 For injuries that were not listed on the Table,
however, petitioners would have to prove them based on a preponderance of the evidence.169
The VICP requires that petitioners sue HHS; petitioners cannot sue manufacturers or
healthcare practitioners in the Program.170 HHS is the respondent for all vaccine injury claims in
the VICP. The rationale for this protection of industry was to ensure a stable childhood vaccine
supply and to keep vaccine prices affordable.171 The source of VICP compensation is the
Vaccine Injury Trust Fund, a fund now containing $3.2 billion collected from an excise tax of
$.75 imposed on the sale of every vaccine.172
Petitioners try cases in the VICP before Special Masters of the Court of Federal Claims.
Eight Special Masters act as finders of fact and law. There are no jury trials.173 The VICP is
meant to be informal, without reliance on the federal rules of evidence and civil procedure.174
Congress intended this informality to benefit the petitioners and Congress expected that the
overwhelming majority of claims would be resolved administratively, where detailed rules of
evidence would not be necessary. The statute also requires that the Secretary of HHS “undertake
reasonable efforts to inform the public of the availability of the Program.”175
Petitioners are entitled to receive $250,000 in the event of a vaccine-related death and a
maximum amount of $250,000 for pain and suffering.176 These caps have not changed since
1986. The Act also provides for “reasonable attorney’s fees and costs” for bringing a petition so
166
Id. § 300aa-14.
Id.
168
Id.
169
Id. § 300aa-13(a)(1).
170
Id. § 300aa-11(a).
171
See, e.g., Calandrillo, supra note 22, at 408 (“Vaccine manufacturers quickly learned their lesson and threatened
to halt production unless guaranteed indemnification by the federal government. As a result, vaccine shortages
ensued, prices skyrocketed, and Congress was forced into action.”).
172
Human Resources Services Commission: National Vaccine Injury Compensation Program, Vaccine Injury
Compensation Trust Fund, http://www.hrsa.gov/vaccinecompensation/VIC_Trust_Fund.htm (“The Trust Fund is
funded by a $0.75 excise tax on each dose of vaccine purchased (i.e., each disease prevented in a dose of
vaccine).”).
173
42 U.S.C. § 300aa-11.
174
Vaccine Rules of U.S. Fed. Cl., Fed. Cl. R. app. 8(b)(1) (“In receiving evidence, the special master will not be
bound by common law or statutory rules of evidence but must consider all relevant and reliable evidence governed
by principles of fundamental fairness to both parties.”), available at http://www.uscfc.uscourts.gov/sites/default/
files/Vaccinerules_20100111_v4.pdf.
175
42 U.S.C. § 300aa-10.
176
Id. § 300aa-15.
167
22
that petitioners do not have to pay lawyers out of pocket or out of the proceeds of a judgment, as
they would have to do in civil court under a contingency fee arrangement.177
The Law requires that claimants file petitions “no more than 36 months after the first
symptom or manifestation of onset or of the significant aggravation of such injury after the
administration of the vaccine.”178 This three year statute of limitations is considerably shorter
than most state tort statutes for tort injury to minors.
In perhaps the most significant part of the statute, the Law restricts vaccine
manufacturers’ liability for those vaccines included on ACIP’s recommended childhood
schedule.179 Under the Law’s terms, starting in 1988, no vaccine manufacturer was liable for a
vaccine-related injury or death from one of the ACIP-recommended vaccines “if the injury or
death resulted from side effects that were unavoidable even though the vaccine was properly
prepared and was accompanied by proper directions and warnings.”180 Utilizing language from
the Second Restatement of Torts, the Law includes this somewhat opaque protection for
industry.
The U.S. Supreme Court will hear Bruesewitz v. Wyeth, a case interpreting this provision,
in October 2010, in part to resolve a split in interpretation between the Supreme Court of
Georgia and the Third Circuit Court of Appeals. In 2008, the Supreme Court of Georgia held
that civil courts must decide on a case-by-case basis whether a vaccine-related injury is
unavoidable for claims of vaccine design defect.181 By contrast, in 2009, the Third Circuit Court
of Appeals held that all vaccine injuries allegedly due to design defect are “unavoidable” under
the 1986 Law.182 The facts of the case from the Third Circuit make up the vignette at the
beginning of the article.
In addition to broad liability protection, the Law provides another important protection to
manufacturers.183 Responding to Reyes v. Wyeth, the Law provides that vaccine manufacturers
are not liable for damages for failure to give direct warnings to those being vaccinated.184
Resting on the “learned intermediary” doctrine, that it is sufficient to inform doctors of the risks,
manufacturers bear no obligation to provide accurate or complete information to those actually
vaccinated.185
177
Id.
Id. § 300aa-16.
179
Id. § 300aa-22.
180
Id. § 300aa-22(b)(1).
181
Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008).
182
Bruesewitz v. Wyeth Inc., 561 F.3d 233 (3rd Cir. 2009), cert. granted, 130 S. Ct. 1734 (2010).
183
Id. § 300aa-22(c).
184
Id. (“solely due to the manufacturers’ failure to provide direct warnings to the injured party of the potential
dangers resulting from the administration of the vaccine….”)
185
Id.
178
23
Complementing manufacturers’ relief from disclosure requirements, another provision
exempts doctors from substantial disclosure requirements. It tasks the HHS Secretary to
“develop and disseminate vaccine information materials.”186 It states that these materials should
outline the benefits and risks of vaccines and the availability of the VICP.187 Doctors are obliged
to provide families with these information materials.
Other provisions in the Law establish mandatory procedures in the event that petitioners
reject the VICP judgment and bring claims against manufacturers in civil court.188 These
provisions establish that trials must be held in three stages: liability, general damages and
punitive damages.189 Punitive damages may be awarded only in the event of fraud or other
criminal or illegal activity relating to the vaccine safety and effectiveness.190
Furthering vaccine safety and surveillance, the Law requires certain recordkeeping by
healthcare providers and industry.191 The Law also requires the Secretary of HHS “to promote
the development of childhood vaccines that result in fewer and less serious adverse reactions”
than those on the market in 1986.192 And it creates the formal opportunity for citizens’ actions
against the HHS Secretary to ensure that the Secretary performs her duties. With broad,
bipartisan support, the Law took effect in 1987.
III.
The Effects of U.S. Vaccine Laws
By law, American children do not have three fundamental protections regarding vaccines:
(1) they do not enjoy free choice regarding vaccines if they wish to attend public school (and this
is also true for many private schools); (2) they are not entitled to accurate and complete
information about the contents and risks of their compulsory vaccines; and (3) they are not
entitled to sue vaccine manufacturers in the event of vaccine-induced injury without first filing a
claim in the VICP. These deprivations of ordinary tort law protections, created by Jacobson,
Zucht and the 1986 Law, have led to undesirable and unintended consequences. These laws
collectively were meant to ensure access to necessary, safe vaccines; meaningful information to
parents about vaccines; improvements in overall vaccine safety; and generous and swift
compensation in the event of injury. They intended to ensure a framework for rational, unbiased
decisions at the federal and state levels for the public health and safety, and especially for
children.
But these are not the results in fact. The laws that apply to childhood vaccination mandates
in practice permit conflicts of interest; inadequate safety science and surveillance; undercompensation of vaccine-injured children; insufficient warnings about the risks of vaccines; and
186
187
188
189
190
191
192
Id. § 300aa-26.
Id.
Id. § 300aa-21.
Id. § 300aa-23.
Id. § 300aa-23(d).
Id. § 300aa-25; Id. § 300aa-28.
Id. § 300aa-27.
24
severe sanctions for non-compliance with vaccination mandates. They also may have
inadvertently contributed to the poor state of childhood health.
These distorted results arise from tensions in and among these laws. Conflicts in the
1986 Law are apparent at first glance. By locating vaccine promotion, safety and compensation
under one umbrella at HHS, Congress created the risk of trade-offs among competing goals.
Revenue-generating vaccine development and promotion have enjoyed priority over vaccine
safety science and injury compensation since the Law’s inception.193
The 1986 Law’s paradigm of optimal prevention, which differs fundamentally from
Jacobson, creates additional tensions. Article 1 states that the purpose of the National Vaccine
Program is to “achieve optimal prevention of human infectious diseases through immunization
and to achieve optimal prevention of adverse reactions to vaccines.”194 While building on the
premises of Jacobson and Zucht, the 1986 Law shifts the framework for compulsory vaccination
from emergency, necessity and imminent harm to “optimal prevention.” The 1986 Law also
changes the effective decision makers for vaccine policy. Now, instead of decentralized state
legislatures and school boards making almost all vaccination decisions, ACIP, the federal
advisory body, wields critical central influence. And ACIP’s touchstone is “optimal prevention,”
not necessity, which has not been legally defined over centuries in the way that “necessity” has
been.
Another tension is between the utilitarian goal to serve the majority’s health and to
compensate for the minority’s adverse reactions to vaccines. The 1986 Law for the first time
publicly acknowledged that universal compulsory vaccination is likely to cause permanent injury
and death to some infants and children. The 1986 Law highlights the troubling issue about
whether it is ethical to compel non-emergency, preventive measures on children for school
attendance when Congress has acknowledged that these measures are likely to cause injury and
death to some. This uncomfortable truth is one that vaccine proponents might prefer to obscure,
as discussed below.
The purpose of the 1986 Law was to ensure the safety and reliability of the seven
vaccines children then received – polio, diphtheria, pertussis, tetanus, measles, mumps and
rubella.195 But in contrast to that purpose, ACIP now recommends 70 doses of 16 vaccines to
children, including vaccines for diseases rarely fatal in the United States, such as varicella and
rotavirus, and diseases not contagious through ordinary social contact, such as hepatitis B and
193
For instance, after the Gulf oil spill, the Obama Administration proposed separating the Minerals Management
Service into two agencies – one responsible for inspecting oil rigs and ensuring safety, and the other responsible for
overseeing leases and collecting royalty payments. John M. Broder, U.S. to Split Up Agency Policing the Oil
Industry, N.Y. TIMES (May 11, 2010), http://www.nytimes.com/2010/05/12/us/12interior.html.
194
42 U.S.C. § 300aa-1.
195
Recommended Schedule for Active Immunization of Normal Infants and Children, 1983 Childhood
Immunization Schedule, http://www.cdc.gov/vaccines/pubs/images/schedule1983s.jpg (last visited Aug. 20, 2010).
25
human papilloma virus.196 ACIP recommendations are the legal basis for compulsory
vaccinations for almost all children in the United States. While states do not generally require all
the vaccines that ACIP recommends, state mandates start with the ACIP schedule.
Necessity no longer determines the validity of state childhood vaccination mandates,
although Jacobson has never been overruled. New vaccine mandates are guided by financial
returns on low prevalence diseases, not protection of the entire population against imminent
harm.197 While the 1986 Law’s “optimal prevention” language may justify compulsion for low
prevalence diseases, Jacobson’s requirement for necessity does not.
A. Inadequate Safety
To many knowledgeable critics, the safety of the childhood vaccine program is
inadequate. The 1986 Law’s removal of ordinary product liability and disclosure requirements
arguably created disincentives for industry and medicine to vigorously pursue a safety agenda.
Because of Jacobson, Zucht and the 1986 Law, children lack the ordinary tort law protections of
informed consent and the right to sue the manufacturer directly, yet they are compelled to accept
medical interventions which are by definition unsafe.
There are several major safety concerns: (1) inadequate testing of vaccines, individually
and cumulatively; (2) insufficient attention to vaccine additives; (3) the failure to screen out
vulnerable subjects; (4) insufficient incentives and funding for vaccine safety; and (5)
government discouragement of discourse about vaccine safety.
Many credible voices in the medical and scientific communities, including Dr. Louis
Cooper, a vaccine inventor and the former President of the American Academy of Pediatrics,
have acknowledged that vaccine safety is inadequate.198 With respect to the science purportedly
proving no association between vaccines and autism, Dr. Bernadine Healy, the former Director
of the National Institutes of Health, has stated simply “the question has not been answered.”199
Dr. Healy has been sharply critical of a medical community unwilling to investigate the tens of
196
Recommended Immunization Schedule for Persons Aged 0 Through 6 Years – United States, 2010,
http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2010/10_0-6yrs-schedule-pr.pdf (last visited Sep. 4,
2010); Recommended Immunization Schedule for Persons Aged 7 Through 18 Years – United States, 2010,
http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2010/10_7-18yrs-schedule-pr.pdf (last visited Sep. 4,
2010).
197
Eileen Salinsky & Cole Werble, The Vaccine Industry: Does It Need a Shot In the Arm?, NAT'L HEALTH POL'Y
FORUM 27-28 (2006), available at http://www.nhpf.org/library/background-papers/BP_VaccineIndustry_01-2506.pdf (“The twin incentives of the VFC [Vaccines For Children] market enhancement and the [tort liability]
protections from the National Vaccine Injury Compensation Program have acted to make childhood vaccines very
attractive to vaccine companies. Manufacturers are pursuing products for diseases with relatively low prevalence
levels and are still securing relatively high prices for the new products.”)
198
Lou Cooper et al., Protecting Public Trust in Immunization, 122 PEDIATRICS 149, 152 (2008) at 151.
199
Interview with Dr. Healy at
http://www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml.
26
thousands of children with regressive autism whose parents allege that vaccines contributed to
their children’s disability.200
1. Inadequate Vaccine Testing
While the 1986 Law should ensure robust safety testing of vaccines, it does not. Testing
for individual vaccines may be done on small control groups;201 adverse reactions in clinical
trials may be found to be coincidental;202 safety tests may be designed to achieve desired results
rather than actual assessments;203 and vaccines may not have been evaluated for “carcinogenic,
mutagenic potential or impairment of fertility.”204
There have been almost no scientific studies assessing the safety of the federallyrecommended childhood vaccination schedule as a whole, so its overall cost-benefit ratio is
unknown. The FDA and CDC test and approve vaccines individually, not as part of the overall
vaccination schedule. For example, the federal government recommends that at a baby’s twomonth doctor visit, the baby receive the Hepatitis B, rotavirus, diphtheria, tetanus, pertussis,
Haemophilus influenzae type B, pneumococcal and inactivated poliovirus vaccines
simultaneously. In other words, the baby is recommended to receive eight vaccines at once
containing a wide array of chemical and biological agents.205 While a baby receives these
vaccines together, the vaccines have not been tested together. At a meeting of the National
Vaccine Advisory Committee in 1995, leading government vaccine safety expert Dr. Edward
200
Id . ("What we’re seeing in the bulk of the population: vaccines are safe. But there may be this susceptible group.
The fact that there is concern, that you don’t want to know that susceptible group is a real disappointment to me. If
you know that susceptible group, you can save those children. If you turn your back on the notion that there is a
susceptible group…what can I say?")
201
See, e.g. only 143 infants and children (up to age 10) were given the Hepatitis B vaccine before it was federally
recommended. They were monitored for 5 days. Merck Recombivax HB, Hepatitis B Vaccine (Recombinant),
http://www.merck.com/product/usa/pi_circulars/r/recombivax_ hb/recombivax_pi.pdf.
202
See, e.g., Sanofi Pasteur Poliovirus Vaccine Inactivated IPOL,http://www.fda.gov/downloads/biologicsblood
vaccines/vaccines/approvedproducts/ucm133479.pdf (“Although no causal relationship has been established, deaths
have occurred in temporal association after…IPV.”).
203
See, e.g., in Merck’s placebo-controlled tests before gaining approval of the Gardasil vaccine, it used a solution
containing 225 mcg of aluminum as its placebo rather than a typical placebo of water or saline. Merck Highlights of
Prescribing Information, http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf; see also Blaxill,
infra note 251.
204
See, e.g., Merck & Co. Inc., M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live), http://www.fda.gov/
downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf (last visited Aug. 16, 2010)
(noting that the vaccines had “not been evaluated for carcinogenic or mutagenic potential, or potential to impair
fertility”); see also Sanofi Pasteur, Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed, Inactivated
Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate Vaccine) Pentacel,
http://www.doh.state.fl.us/disease_ctrl/immune/files/Pentacel-VS-20Jun08.pdf (noting that no studies had been
performed to “evaluate carcinogenicity, mutagenic potential, or impairment of fertility”).
205
Recommended Immunization Schedule for Persons Aged 0 Through 18 Years --- United States, 2010,
MORBIDITY & MORTALITY WKLY R. (2007),
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5851a6.htm?s_cid=mm5851a6_e.
27
Marcuse acknowledged that “no medical studies exist which prove the safety of this practice
[combining multiple vaccines, such as measles, mumps and rubella].”206
2. Dangerous Vaccine Additives
Vaccines today contain many known toxic substances. In addition to the pathogenic
agents that trigger intended immune responses, vaccines contain preservatives to retain potency
and adjuvants to boost immune response. These added ingredients permit smaller amounts of
antigen and fewer vaccine doses to achieve documented immunity. Supplemental vaccine
ingredients in a variety of vaccines include aluminum hydroxide, formaldehyde, thimerosal
(mercury), bovine extract, ammonium sulfate, mouse serum protein, MSG, monkey kidney
tissue, egg albumin, lactose, glucose and casein, to name a few.207 Simian Virus 40,
inadvertently contained in intramuscular polio vaccines, has been associated with several
different human cancers, including mesotheliomas and brain cancers.208
Certain vaccine ingredients used as preservatives and adjuvants, such as aluminum and
mercury, are recognized neurotoxins.209 The amount of mercury used in most mandated
vaccines throughout the 1990’s and in most seasonal flu vaccines today is 25 micrograms or
25,000 parts per billion – over 100 times the 200 parts per billion classification the
Environmental Protection Agency sets for hazardous waste.210 On mercury’s long-time use as a
vaccine preservative, Dr. George Lucier, former Director of the National Toxicology Program of
the National Institute of Environmental Health Sciences, wrote:
I conclude that the justification for considering thimerosal or merthiolate as safe
was inadequate and flawed, information on alternative preservatives was ignored,
the vaccine manufacturers ignored a significant body of knowledge on health
206
Kristine Severyn, Jacobson v. Massachusetts: Impact on Informed Consent and Vaccine Policy, 5 J. PHARMACY
& L. 249, 269, n. 141 (1995-1996) (reporting statement of Dr. Edward Marcuse, chair of the National Vaccine
Advisory Committee, at Mar. 1, 1995 meeting of the Advisory Commission on Childhood Vaccines (Transcript
available from: Advisory Commission on Childhood Vaccines, Division of Vaccine Injury Compensation, U.S.
Public Health Service, Parklawn Building, Room 8a-35, 5600 Fishers Lane, Rockville, Maryland 20857)).
207
CDC Vaccine Excipient & Media Summary, Part 2: Excipients Included in U.S. Vaccines, By Vaccine (March
2010), http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf.
208
DEBBIE BOOKCHIN & JIM SCHUMACHER, THE VIRUS AND THE VACCINE: CONTAMINATED VACCINE, DEADLY
CANCERS, AND GOVERNMENT NEGLECT 215 (2004) (noting that studies describing an association between Simian
Virus 40 and human cancers, including mesotheliomas, brain and bone cancers have been published).
209
For neurotoxic effects of mercury, see U.S. Environmental Protection Agency at
http://www.epa.gov/mercury/health.htm, and for aluminum, see National Center for Biotechnology Information at
http://www.ncbi.nlm.nih.gov/pubmed/2198876.
210
EPA National Primary Drinking Water Regulations, http://www.epa.gov/ogwdw000/consumer/pdf /mcl.pdf ; see
also FDA Vaccines, Blood, & Biologics, http://www.fda.gov/
BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228.
28
effects for at least 50 years and that the vaccine manufacturers did not conduct
necessary toxicology studies to establish safety.211
3. Failure to Screen Vulnerable Subjects
One of the 1986 Law’s objectives is to prevent adverse vaccine reactions. But this
objective has not been vigorously pursued. Little effort has been made to preemptively screen
out those most likely to be injured by vaccination. As one vaccine safety advocate said:
The fact that there has been no attention paid by industry and government to
minimizing vaccine risks, including no scientific research – as the Act called for –
into identifying individuals at high risk for suffering vaccine adverse responses so
their lives can be spared – speaks volumes about the disconnect between the
intent of Congress to prevent vaccine injuries and deaths and the intent of those
operating the federal compensation system to deny they exist.212
A long list of medical injuries has been proven to be more likely than not due to vaccines
in the VICP. These proceedings rest almost exclusively on peer-reviewed science and medical
testimony, requiring the same standards for evidence as in civil proceedings, although the federal
rules of evidence do not apply formally.213 In these proceedings, the Court of Federal Claims has
concluded that many medical injuries were due to vaccines, including optic neuritis, acutedisseminated encephalomyelitis, multiple sclerosis, Guillain-Barre Syndrome, transverse
myelitis, seizure disorder, chronic inflammatory demyelinating polyneuropathy, scarring,
hemolytic anemia, familial hemophagocytic lymphohistiocytosis (an inherited immune
deficiency), attention deficit disorder, learning disabilities, behavioral problems, mental
retardation in a child who became autistic, pervasive developmental delay, and death.214
Presumably these cases could be studied for use in devising screening models of what kinds of
children are at highest risk of injury, but this is not being done.
4. Insufficient Incentives and Funding for Vaccine Safety
The 1986 Law states vaccine safety as one of its objectives. But this objective remains
unfulfilled. The hearings preceding the 1986 Law looked at whether liability protection for
industry might diminish its incentives to achieve vaccine safety. In testifying before Congress,
Dr. Jonas Salk, one of the inventors of the polio vaccine, favored the 1986 Law but expressed
211
George Lucier, “Thimerosol is a Developmental Neurotoxicant,” report available at
http://www.vtce.org/mercury/ lucier.pdf.
212
Barbara Loe Fisher, Co-Founder and President, Nat'l Vaccine Info. Ctr., Statement to Advisory Comm'n on
Childhood Vaccines: The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? (Nov. 18,
2008), http://www.nvic.org/injury-compensation/vaccineinjury.aspx.
213
Vaccine Rules of U.S. Fed. Cl., Fed. Cl. R. app. 8(b)(1), supra note 174.
214
Brief for Petitioner-Appellant at 21-24, Cedillo v. Sec'y of Health & Human Servs., No. 2010-5004 (Fed. Cir.
Jan. 19, 2010).
29
concern that it might “remov[e]…the incentive for manufacturers and the scientific community
to improve existing vaccines.”215
Dr. Robert Chen, Chief, Vaccine Safety and Development of the CDC, acknowledged
this problem again in 1995 when he said “in theory at least one might say that, by creating a nofault compensation system, it takes a bit more of the pressure off of the manufacturers and may
reduce the incentive at least in the private sector for vaccine safety research.”216 Dr. Chen made
clear in the same presentation, though, that the pursuit of vaccine safety science within the
government was not much better: “the only line item for vaccine safety research is I think on the
order of a little less than $2 million per year. That basically covers basic operation of VAERS
[Vaccine Adverse Event Reporting System], period, and nothing else. Everything else has been
begged, borrowed and stolen.”217
According to Dr. Chen’s testimony, in 1995, vaccine safety was .2% of the total vaccine
budget of about $1 billion.218 Today, the situation is not significantly different. In a 2008 article
in Pediatrics, Dr. Louis Cooper, vaccine inventor and former President of the American
Academy of Pediatrics, lamented that the vaccine safety science budget was $20 million out of a
total vaccine budget for purchase, promotion and delivery of $4 billion, or .5%.219
Liability protection for industry and insufficient safety science funding have not served
the interests of children’s safety.
5. Government Discouragement of Public Discourse on Vaccine Safety
Secretary of Health and Human Services Sebelius recently acknowledged that HHS
requested the media not to report on critics of vaccine safety during the H1N1 swine flu
epidemic.220 She said in a magazine interview, “We have reached out to media outlets to try to
get them to not give the views of these people [vaccine safety critics] equal weight in their
reporting to what science has shown and continues to show about the safety of vaccines.”221
Failure to report criticism of vaccine safety is unlikely to resolve the serious questions that
surround it.
215
Id. at 262.
Id. n. 97 (citing Advisory Commission on Childhood Vaccines (ACCV) and National Vaccine Advisory
Committee (NVAC) Subcommittees on Vaccine Safety, May 31, 1995, Parklawn Building, Conference
Room D, Rockville, Maryland, at 75. Transcript available from Division of Vaccine Injury Compensation,
Parklawn Building, Room 8A-35, 5600 Fishers Lane, Rockville, Maryland 20857).
217
Id. at 270, n. 142.
218
Id.
219
Cooper et al., supra note 198.
220
Arthur Allen, H1N1: The Report Card, READER'S DIGEST (Mar. 2009), http://www.rd.com/healthslideshows/h1n1-the-report-card/article174741-1.html (interview with HHS Secretary Sebelius).
221
Id.
216
30
B. Failure to Compensate Vaccine Injury Victims Generously
The 1986 Law requires that the VICP compensate vaccine-injured children generously.
The VICP has failed in this responsibility. The legislative history of the Law shows that
Congress saw the VICP as a way to maintain the public trust in vaccines and to honor the social
compact. To compensate an injured family is similar to taking care of war veterans – the society
is providing for those who suffered for the collective good. Congress intended the VICP to
ensure that society supports the individual families who bear the brunt of “unavoidably unsafe”
compulsory vaccines.
There is another way to view vaccine injury compensation, however, and that is to see it
as undermining the public message that “vaccines are safe and effective.” According to this
second view, acknowledging injury is potentially dangerous, undermining the public narrative of
overwhelming vaccine safety. HHS and DOJ actions suggest that they view vaccine injury
compensation in the second way, seeing awards as undermining the public trust in a universal
vaccine program.
In the early 1990’s, just a few years after the 1986 Law took effect, HHS used its
discretionary authority to eliminate almost all on-Table adverse events creating presumptions for
recovery.222 These actions were despite the purpose of the VICP to provide a presumptive, nofault administrative remedy. HHS Secretary Shalala removed “residual seizure disorder” from
the Table of Vaccine Injury, nullifying the presumptive compensation category for children who
suffered seizures immediately after the DPT vaccine. As a result, almost all DPT seizure
disorder cases became off-Table, requiring litigation. Those cases met with varying results.223
HHS also redefined “encephalopathy,” a recognized compensable injury, to exclude almost all
cases from on-Table compensation.224 Despite Congress’ intent that the VICP be an
administrative program, today almost all cases must be litigated to establish causation.
Vaccine-injured petitioners challenged and appealed these HHS administrative changes
to the First Circuit Court of Appeals, which upheld HHS' administrative actions.225 These
changes altered the character of the VICP fundamentally. According to Barbara Loe Fisher, a
leading vaccine safety advocate, these HHS actions “turned the administrative compensation
222
60 Fed. Reg. 7678 (Feb. 8, 1995).
See Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (allowing compensation for
seizures caused by DPT vaccine); but see Bruesewitz v. Sec'y of Health & Human Servs., 2002 U.S. Claims LEXIS
364 (Fed. Cl. 2002) (denying compensation for seizure disorder allegedly caused by DPT vaccine).
224
“Proposed Changes to the Vaccine Injury Table,” HHS memo dated Aug. 21, 1992, at
http://www.hhs.gov/news/press/pre1995pres/920821.txt.
225
O'Connell v. Shalala, 79 F.3d 170 (1st Cir. 1996) (holding that the Secretary of Health and Human Services had
the power to promulgate a rule removing residual seizure disorder from the vaccine injury table and changing the
definition of encephalopathy). The petitioners also brought an appellate suit in the Court of Federal Claims after
they were denied compensation, but because they rested their arguments on the same constitutional grounds they
used in the First Circuit case, the Court held that the suit was barred by res judicata. O'Connell v. Sec'y of Health &
Human Servs., 1999 U.S. App. LEXIS 28427 (1999), cert. denied, 531 U.S. 812 (2000).
223
31
process into a highly adversarial, lengthy, expensive, traumatic and unfair imitation of a court
trial for vaccine victims and their attorneys.”226
The failure to add new presumptions for recovery is another indicator of HHS’
disinclination to grant compensation. Despite the fact that nine new vaccines have been added to
the ACIP childhood vaccine schedule since 1986, more than doubling the possibility of vaccine
injury, only one new Table injury has been added – anaphylaxis within 4 hours of the hepatitis B
vaccine.227
The former Chief Special Master, Gary Golkiewicz, acknowledged the Program’s bias
against petitioners.228 After HHS administrative changes to the Program in 1998, he is quoted in
a recent book on vaccines as having said:
[the government] altered the game so that it’s clearly in their favor. This group
[HHS and DOJ] has a vested interest in vaccines being good. It doesn’t take a
mental giant to see the fundamental unfairness in this.229
In a later speech to the Advisory Commission on Childhood Vaccines, Special Master
Golkiewicz again acknowledged the conflict between compensation and what he called
“vaccine’s integrity,” or the possibility that injuries occurring shortly after vaccination might be
unrelated to vaccines. He acknowledged that “there’s a tension between these two objectives [to
compensate and to protect the “vaccine’s integrity”], a tension that affects dramatically the
litigation of the cases, the parties’ arguments and ultimately who wins.”230 He acknowledged the
conflict HHS perceives.
Since its creation, the VICP has compensated nearly 2,500 victims of vaccine injury and
has dispensed over $2 billion in damages.231 But more than 4 out of 5 claimants have not
received compensation.232 In what Congress intended to be a non-adversarial forum to provide
generous administrative compensation, it is striking that over 80% of claims have gone
uncompensated.
Although the 1986 Law requires “reasonable efforts” to inform the public about the
existence of the VICP, the total budget for publicizing the program is $10,000.233 The total
226
227
228
Fisher, supra note 212.
Vaccine Injury Table, supra note 165.
ARTHUR ALLEN, VACCINE: THE CONTROVERSIAL STORY OF MEDICINE'S GREATEST LIFESAVER 293 (2007).
229
Id.
Chief Special Master Gary Golkiewicz, Presentation to the Advisory Commission on Childhood Vaccines (Mar.
6-7, 2008) available at http://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm.
231
National Vaccine Injury Compensation Program, supra note 4.
232
Id.
233
Comments of Dr. Geoffrey Evans, Transcript at 46, Dept. of Health and Human Servs., Advisory Commission
on Childhood Vaccines (June 5, 2009), http://www.hrsa.gov/vaccinecompensation/Docs/Transcript_ACCV-6-509.pdf.
230
32
amount of compensation the VICP awards depends in part on the number of people aware
of the VICP who file timely claims. The $4 billion budget for vaccine promotion and
development dwarfs this outreach budget and at least raises the question whether HHS is
taking “reasonable efforts” in good faith to let the public know about the availability of
compensation for vaccine injury.
Due to several factors, one can reasonably infer that the VICP has compensated
fewer cases than the actual number of vaccine injury cases since the Law has been in effect.
These factors include ignorance about vaccine injury; ignorance about the compensation
program; a three-year statute of limitations; an adversarial litigation context; inconsistent
judgments by Special Masters; VICP’s deterrence of experienced lawyers and medical
experts through delayed and below-market compensation; and unavailability of medical
documentation to prevail on claims. The VICP has failed to compensate generously,
despite Congress’ intent.
C. Failure to Provide Accurate Information
The norm of informed consent in medicine requires doctors to provide extensive
information about the known risks of interventions to patients and to allow the patients to make
the ultimate decisions about medical interventions and treatments.234 Similarly, drug
manufacturers are in general required by law to provide accurate and complete information about
drug risks with their products. Under Jacobson, Zucht and the 1986 Law, however, these norms
do not apply to compulsory vaccines for children. The 1986 Law does not require doctors or
vaccine manufacturers to give complete warnings directly to the person or guardian of the child
being vaccinated. It requires that doctors give government-produced ‘information materials’ and
requires that manufacturers provide proper warnings to doctors only, who are considered to be
“learned intermediaries.”235 Both industry and the medical community lobbied for this lowered
information standard after Reyes v. Wyeth.236
The 1986 Law initially required more information than what parents receive today. The
1986 Law specified ten items for Vaccine Information Materials (VIMs) to cover.237 The initial
versions were 12 pages long and required parental signature. But pediatricians found the
brochures were “scaring” parents and took too much time.238 The American Academy of
234
See, e.g., 61 AM. JUR. 2D Physicians, Surgeons, Etc. § 175 (2010) (“The doctrine of informed consent imposes
on a physician the duty to explain the procedure to the patient and to warn him of any material risks or dangers
inherent in all collateral therapy, so as to enable the patient to make an intelligent and informed choice about
whether or not to undergo the treatment.”).
235
See, e.g., 28 C.J.S. Drugs and Narcotics § 128 (2010) (“Under the learned-intermediary doctrine, the
manufacturer of a prescription drug or medical device does not have a duty to warn the patient, consumer or general
public of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a
learned intermediary between the patient and the manufacturer.”).
236
Reyes v. Wyeth, supra notes 122 to 130 and accompanying text.
237
See Severyn, supra note 206, at 270 (citing 42 U.S.C. § 300aa-26(c) (1986)).
238
Id. at 270-271.
33
Pediatrics submitted legislation to shorten the VIMs. Congress enacted the proposed changes in
1993. Instead of ten information items, statements for parents now contained four: the benefits
of the vaccine, the risks, one sentence about the VICP and a reference to the CDC for further
information. Parents’ signatures were also eliminated in this change. In an advisory to doctors,
the CDC wrote that the new VIMs “provide enough information that anyone reading the
materials should be adequately informed.”239
The current Measles, Mumps and Rubella VIM states under its heading of “Severe
Problems (Very Rare)”:
Serious allergic reaction (less than 1 out of a million doses). Several other severe
problems have been known to occur after a child gets MMR vaccine (sic). But
this happens so rarely, experts cannot be sure whether they are caused by the
vaccine or not. These include: deafness, long-term seizures, coma or lowered
consciousness, permanent brain damage.240
That “experts cannot be sure whether they are caused by the vaccine or not” is inaccurate.
The VICP has compensated 301 cases of MMR-induced vaccine injury under the standard of
more likely than not.241 This VIM inaccurately describes the risk of vaccine injury. The Allison
v. Merck court described above likely would have found this warning improper under the pre1986 Law standards, but it suffices under the 1986 Law.
The amended 1986 Law deprives parents of thorough information about vaccines. And
in addition to parental ignorance about vaccine adverse reactions, some doctors may lack
knowledge, dismissing medical problems after vaccines as coincidental.242 Vulnerable children
may be at higher risk of suffering adverse vaccine reactions than necessary because of
inadequate knowledge, both among parents and doctors. The 1986 Law has facilitated this
possibility.
D. Conflicts of Interest and Troubling Aspects of the Vaccine Industry
1. Conflicts of Interest
Part of Jacobson’s rationale for deference to state legislatures was their representative
nature; legislatures by their nature are required to take account of differing views in the
population. Indeed, if the legislature makes bad choices, the electorate can reverse those choices
239
Id. at 272 (citing Preventative Health Amendments of 1993 tit. VII, 708, H.R. 2202, 103d Cong., 1st Sess.,
Vaccine Information Materials: Questions and Answers, at 8Q (1993)(included in mailing to Ohio physicians)).
240
Measles, Mumps, & Rubella (MMR) Vaccines: What You Need To Know (Mar. 13, 2008), http://www.cdc.gov/
vaccines/pubs/vis/downloads/vis-mmr.pdf.
241
National Vaccine Injury Compensation Program, supra note 4 (reporting that the National Vaccine Injury
Compensation Program has compensated 2,472 total claims, with 301 of them being related to MMR vaccine).
242
Fisher, supra note 212.
34
and unseat the legislators through popular elections. But ACIP is now the driving force behind
vaccination mandates, a federal advisory body with little public participation and no direct
accountability to voters. Because of this change in the locus of decision-making from legislators
to ACIP, codified by the 1986 Law, there are perhaps greater risks of conflicts of interest. Many
ACIP advisors have ties to industry and their views and judgments may be motivated more by
financial and professional self-interest than by protecting the public health.
In 2000, a Congressional report on “Conflicts of Interest in Vaccine Policy Making,”
identified pervasive conflicts of interest in the FDA and CDC advisory bodies that make national
vaccine policy.243 The report looked in detail at the conflict of interests in the decision making
that led the FDA and CDC to approve Merck’s Rotashield vaccine against rotavirus, an intestinal
disease of infants.244 Merck voluntarily withdrew Rotashield from the market thirteen months
after launch due to serious adverse reactions.245 The House Government Reform Committee
found numerous problems with the approval of Rotashield and with vaccine approvals in
general:








advisers’ financial ties to vaccine manufacturers;
little unbiased public participation;
insufficient use of conflict of interest waivers;
advisers’ permitted stock ownership in companies affected by their decisions;
advisers’ lack of disclosure of partisan expert witness work;
advisers who held vaccine patents approving vaccines for the same disease;
excessively long terms for committee members; and
liaison members’ undisclosed ties to vaccine manufacturers.246
There is little evidence that the CDC or FDA implemented the report’s recommendations.
In 2008, eight years later, an Office of Inspector General of HHS study of disclosure and conflict
waivers found that 97% of Special Government Advisers on committees at the CDC failed to
disclose necessary information about conflicts of interest,247 prompting criminal investigation of
some.248
243
STAFF OF H. GOV. REFORM COMM., 106TH CONG., CONFLICTS OF INTEREST IN VACCINE POLICY MAKING 41
(Comm. Print 4024), http://www.nvic.org/nvic-archives/conflicts-of-interest.aspx (“In the interest of public health,
Congress should revise existing law to ensure that advisory committees contributing to vaccine policymaking are not
unduly affected by individuals with conflicts of interest.”).
244
Id. at 8.
245
Id. at 9.
246
Id. at 2.
247
DEP'T OF HEALTH AND HUMAN SERVICES, OFFICE OF INSPECTOR GEN., OEI-04-07-00260, CDC'S ETHICS
PROGRAM FOR SPECIAL GOVERNMENT EMPLOYEES ON FEDERAL ADVISORY COMMITTEES (2009).
248
Id. at 23 n. 69 (“The cases were forwarded to the OIG Office of Investigations because the waivers were created
pursuant to the criminal conflict-of-interest statute. The OIG Office of Investigations reviewed information
regarding these seven SGEs [special government employees] and determined, largely as a result of CDC’s systemic
lack of oversight of the ethics program for SGEs identified in this report, that the actions of the seven SGEs did not
rise to the level of criminal violations of the conflict-of-interest statute.”).
35
Illustrative of the culture of conflicts of interest is the former Director of the CDC, Dr.
Julie Gerberding. One year after she left the CDC as Director, she joined Merck as the President
of its Vaccine Group.249 During her tenure at CDC, ACIP approved Merck’s Gardasil vaccine
for human papilloma virus against cervical cancer.250 Gardasil is the most expensive vaccine for
the least prevalent disease that ACIP has ever approved and recommended for universal use.
There were well-documented conflicts of interest in the Gardasil approval process. Since
ACIP’s approval in 2007, there have been allegations of severe injury and death from the
vaccine.251
While conflicts of interest in vaccine mandates were identified as a problem at least as
early as 1911,252 what is new is the potential scale of damage from such conflicts. Because all
school children in the country are now subject to 30-45 compulsory vaccines recommended by
ACIP, conflicts of interests may have potentially greater impact than when vaccination mandates
were solely state and local matters. The 1986 Law, which centralized national vaccination policy
and created its infrastructure, facilitated rather than minimized potential conflicts of interest
2. The Pharmaceutical Industry
From the 1980’s through the early 2000’s, the pharmaceutical industry, which produces
vaccines, was the most profitable industry in the United States. In 2002, the combined profits of
the ten largest drug companies in the Fortune 500 had higher net profits, of $35.9 billion, than all
the other 490 companies combined, which had net profits of $33.7 billion.253 Also in 2002, the
pharmaceutical industry employed 675 full-time lobbyists in Washington, more than the number
of people in both Houses of Congress.254 It spent $91 million annually for lobbying.255 In
addition to direct lobbying, the industry funded indirect forms of marketing to promote its
agenda. It funded research, continuing medical education for doctors and health advocacy
249
Dr. Julie Gerberding Named President of Merck Vaccines (Dec. 21, 2009), https://merck.com/newsroom/newsrelease-archive/corporate/2009_1221.html.
250
Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization
Practices (ACIP), MORBIDITY & MORTALITY WKLY R. (2007), http://www.cdc.gov/mmwr/preview/mmwrhtml/
rr56e312a1.htm.
251
Mark Blaxill, A License to Kill? Part 1: How A Public-Private Partnership Made the Government Merck’s
Gardasil Partner (May 12, 2010), http://www.ageofautism.com/2010/05/a-license-to-kill-part-1-how-apublicprivate-partnership-made-the-government-mercks-gardasil-partner.html; see also Mark Blaxill, A License to
Kill? Part 2: Who Guards Gardasil’s Guardians? (May 12, 2010), http://www.ageofautism.com/2010/05/a-licenseto-kill-part-2-who-guards-gardasils-guardians.html; Mark Blaxill, A License to Kill? Part 3: After Gardasil’s
Launch, More Victims, More Bad Safety Analysis and a Revolving Door Culture (May 13, 2010),
http://www.ageofautism.com/2010/05/a-license-to-kill-part-3-after-gardasils-launch-more-victims-more-bad-safetyanalysis-and-a-revolvin.html and The Truth About Gardasil, http://truthaboutgardasil.org (alleging that thousands
of girls suffered adverse reactions to Gardasil, including 71 deaths).
252
See supra notes 66 to 70, discussing Rhea v. Bd. of Educ.
253
MARCIA ANGELL, THE TRUTH ABOUT DRUG COMPANIES 11 (2005).
254
Id. at 198.
255
Id.
36
groups,256 such as the Immunization Action Coalition,257 that appear to advance an impartial
health agenda but in fact serve as pharmaceutical marketing agents.
A handful of pharmaceutical corporations dominate the vaccine market, and there are
high barriers to entry. Although there were over 30 vaccine manufacturers in the 1960’s, today
just four corporations produce almost the entire U.S. vaccine supply: Merck, Pfizer (which
recently acquired Wyeth), GlaxoSmithKline and Sanofi Pasteur.258 These companies
manufacture almost 80 percent of the global vaccine market as well.259 Furthermore, these four
suppliers have one primary customer in the U.S.: the federal government. The U.S. government
purchases almost 60 percent of all vaccines in country.260 The corporations have close relations
with HHS, which oversees the agencies that regulate and interface with these industries.
Although the vaccine market is a small part of the overall pharmaceutical market, at
around 1.5 percent,261 it now has high margins and is expanding with double digit growth.262
Vaccine manufacture for the children’s market is a high margin, low risk business. Indeed,
global sales of vaccines reached $22.1 billion in 2009, up 16% from the previous year.263And
industry plans to capitalize on vaccines in the near term, predicting nearly ten percent annual
growth of the market over the next five years, pushing sales to roughly $35 billion.264 Many
“blockbuster” drugs like Lipitor, Plavix and Singulair are going off patent, perhaps leading drug
manufacturers to look to children’s compulsory and recommended vaccines to make up revenue
shortfalls.
In a system this oligarchic, corruption is a concern. But in the vaccine market, these
concerns should be heightened. Because children have abrogated rights to informed consent and
the right to sue under Jacobson, Zucht and the1986 Law, they have relatively few legal rights of
redress. It is particularly troubling that the primary childhood vaccine manufacturers, Pfizer,
Merck and GlaxoSmithKline, have records of fraud and criminal or ethical misconduct in
marketing other drugs where they face ordinary tort liability that they do not face by law in the
vaccine market.
256
Id. at 138.
IAC Funding, Immunization Action Coalition, http://www.immunize.org/aboutus/funding.asp (listing seven drug
companies that donated money in 2010).
258
The Vaccine Industry – An Overview (July 2010), http://www.vaccineethics.org/issue_briefs/industry.php.
257
259
Id.
Id.
261
Id.
262
See Salinsky & Werble, supra note 197, at 12.
263
Linda A. Johnson, Vaccine sales up 16 pct in 2009, still growing, Associated Press, Aug. 13, 2010 available at
http://www.wgal.com/r/24620886/detail.html.
264
Id.; see also Andrew Barry, Wonder Drugs, BARRON'S, June 28, 2010,
http://online.barrons.com/article/SB500014240529
70203296004575320891909686872.html#articleTabs_panel_article%3D1.
260
37
In 2009, Pfizer entered into the largest criminal settlement in U.S. history. It paid a $1.2
billion as a criminal penalty, plus additional fines of over $1 billion.265 The corporation
acknowledged having made false and misleading claims about the safety and effectiveness of its
drugs and promoting off-label, illegal uses. It was a repeat offender, having been charged with
four such violations since 2002.266 The FBI lauded the whistleblowers that came forward to stop
the corporation from “blatantly violating the law and misleading the public through false
marketing claims.”267 Pfizer, through its recent purchase of Wyeth, makes one vaccine among
ACIP-recommended vaccines.268
Merck voluntarily withdrew its anti-inflammatory drug Vioxx from the market in
2004.269 Congressional hearings at that time suggested that up to 55,600 people probably died as
a result of heart attacks and strokes directly linked to Vioxx’s failure to alert users to
contraindications and possible adverse events.270 The Congressional hearings suggested that
Merck knew of the likelihood of these side effects in 1998, before the FDA approved the drug in
1999.271 The approval process suggested conflicts of interest.272 To compensate victims, Merck
entered into a settlement to pay $4.85 billion to nearly 50,000 eligible claimants.273 Merck
manufactures ten vaccines that are among ACIP-recommended vaccines.274
265
Settlement Agreement, 2009, http://www.justice.gov/usao/ma/Press%20Office%20%20Press%20Release%20Files/Pfizer/Pfizer%20Settlement%20Agreement.pdf; see also Pfizer Concludes
Previously Disclosed Settlement Agreement With U.S. Department Of Justice Regarding Past Promotional
Practices: Company Reaches Settlement with States on Related Matter, BUSINESS WIRE, Sep. 2, 2009,
http://www.businesswire.com/portal/site/
home/permalink/ndmViewId=news_view&newsId=20090902005690&newsLang=en. (last visited Sept. 4, 2010).
266
See Pfizer to Pay Record $2.3 Billion Penalty, ASSOCIATED PRESS (Sep. 2, 2009),
http://www.msnbc.msn.com/id/ 32657347/.
267
Id.
268
Complete List of Vaccines Licensed for Immunization and Distribution in the US, FDA Vaccines, Blood, and
Biologics (June 3, 2010), http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/
ucm093833.htm [hereinafter Complete List of Vaccines] (listing Wyeth as the manufacturer of pneumococcal
vaccine).
269
Merck News Release: Merck Announces Voluntary Worldwide Withdrawal of Vioxx, Sep. 30, 2004, https://
merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf.
270
Reporting on Congress's findings during its Vioxx hearings, reporter Susan Dentzer stated, “Graham [an FDA
safety officer whistleblower] then offered an estimate of the scope of the debacle in terms of the number of
Americans who took Vioxx and then experienced additional heart attacks and strokes.” Dr. David Graham clarified,
“This estimate ranges from 88,000 to 139,000 Americans. Of these, 30 to 40 percent probably died.” Susan Dentzer
et al., Drug Failure, Online NewsHour (Nov. 18, 2004), http://www.pbs.org/newshour/bb/health/julydec04/vioxx_11-18.html.
271
Id.
272
Vale Krenik, Note and Comment, “No One Can Serve Two Masters:” A Separation of Powers Solution for
Conflicts of Interest Within the Department of Health and Human Services, 12 TEX. WESLEYAN L. REV. 585 (Spring
2006).
273
Vioxx Settlement Almost Wrapped Up, NewsInferno, Mar. 2, 2010,
http://www.newsinferno.com/archives/18957 (“To settle most of those suits, Merck established a $4.85 billion fund
in November 2007. Merck set up a $4 billion fund for people who claim they suffered heart attacks as a result of
Vioxx, and another $850 million fund for those who suffered ischemic strokes.”).
274
Complete List of Vaccines, supra note 268 (noting that Merck manufactures vaccines for haemophilus B,
hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, pneumococcal, rotavirus, and varicella).
38
In 2010, a Congressional hearing suggested that GlaxoKlineSmith failed to warn the
FDA about the potentially serious side effects of Avandia, its diabetes drug.275 An independent
review of the clinical trial record “found a dozen instances in which patients taking Avandia
appeared to suffer serious heart problems that were not counted in the study’s tally of adverse
events.”276 The failure of the FDA approval system to uncover these undisclosed adverse events
prompted Dr. Jerome Kassirer, former Editor in Chief of the New England Journal of Medicine,
to ask “whether the entire system is corrupt.”277 Glaxo manufactures nine ACIP-recommended
vaccines.278
Certain reports and industry actions raise direct concerns about unethical actions in the
area of childhood vaccines. For example, a memo obtained from Merck in civil discovery
showed that the director of Merck’s vaccine division was concerned about the risks of
cumulative infant mercury exposure from vaccines in 1991, eight years before the federal
government required initial removal of mercury from vaccines.279 Another industry memo
allegedly given by a whistleblower to a reporter and available on the internet, showed that
Wyeth executives instructed vaccine lots to be sold around the country, and not in any
concentrated area, to avoid any appearance that vaccines might cause Sudden Infant Death
Syndrome.280 And regarding thimerosal, the mercury-containing vaccine preservative, Congress
voted to reverse the “Lilly rider” to the Homeland Security Act of 2002, an anonymous rider
attached to the Act to grant the Eli Lily corporation blanket immunity from any side effects that
may have resulted from thimerosal’s past use in childhood vaccines.281
Due in part to the absence of ordinary tort law protections, the vaccine marketplace is
uniquely favorable to industry. Logically, demonstrably predatory corporations selling
compulsory products to a vulnerable population should lead to a high level of government
scrutiny and skepticism. But this is not apparent. On the contrary, government appears to ally
its interests with industry in the arena of vaccines. Examples of the government’s allegiance are
275
Darla Miles, Senate Report: Avandia Maker Knew of Cardiac Risks, ABC EYEWITNESS NEWS, Feb. 20, 2010,
http://abclocal.go.com/ wabc/story?section=news/health&id=7288680.
276
Gardiner Harris, Caustic Government Report Deals Blow to Diabetes Drug, N.Y. TIMES, July 9, 2010,
http://www.nytimes.com/2010/07/10/health/10diabetes.html.
277
Id.
278
Complete List of Vaccines, supra note 268 (noting that GlaxoKlineSmith manufacturers vaccines for diphtheria,
tetanus, pertussis, haemophilus B, hepatitis A, hepatitis B, human papillomavirus, influenza, and rotavirus).
279
Myron Levin, L.A. Times, “'91 Memo Warned of Mercury in Shots,” Feb. 8, 2005 available at
http://www.ahrp.org/infomail/05/02/08.php; electronic copy of 1991 Dr. Maurice Hilleman memo on file with
author.
280
Dan Olmsted, “Olmsted on Autism: 1979 Wyeth Memo on DPT,” Aug. 12, 2008,
http://www.ageofautism.com/2008/08/by-dan-olmsted.html, including pdf of the underlying memo, alleged to be
Wyeth “internal correspondence.”
281
DAVID KIRBY, EVIDENCE OF HARM, MERCURY IN VACCINES AND THE AUTISM EPIDEMIC: A
MEDICAL CONTROVERSY 235-36 (2005).
39
the Department of Justice’s recent amicus brief on behalf of industry in Bruesewitz v. Wyeth282
and HHS Secretary’s Sebelius’ discouragement of press inquiries into vaccine safety.283 Given
this allegiance of government and industry interests, the absence of the ordinary legal protections
to informed consent and the right to sue take on heightened significance.
E. Children’s Health Problems
American infants and children are experiencing widespread chronic health problems.
Fourteen percent have (or have had) asthma;284 9% have attention deficit hyperactivity
disorder;285 8% have a learning disability;286 2% have an allergic condition;287 and 1% has an
autism spectrum disorder,288 with substantially higher rates among boys than girls for many of
these conditions. The prevalence of these disorders is unprecedented. High infant mortality in
the U.S. is similarly troubling. According to Central Intelligence Agency statistics, the U.S.
ranked 28th among world nations for infant mortality, the death rate before one year of age,
behind almost all other developed nations.289
There are plausible links between vaccines and these troubling health statistics.290
Petitions in the Court of Federal Claims for vaccine injury show that many individuals think their
health problems are vaccine-related.291 It is scientifically plausible that childhood vaccines may
play a role in children’s health problems today.
282
Brief for the United States As Amicus Curiae Supporting Respondents, Bruesewitz v. Wyeth, available at
http://www.abanet.org/publiced/preview/briefs/pdfs/09-10/09-152_RespondentAmCuUSA.pdf.
283
See Allen interview with HHS Secretary Sebelius, supra note 220.
284
Summary Health Statistics for U.S. Children: National Health Interview Survey, 2009,
http://www.cdc.gov/nchs/data/series/sr_10/sr10_247.pdf , asthma data at 25.
285
Id. at 27, ADHD data.
286
Id. at 27, learning disability data.
287
Id. at 26, allergy data.
288
CDC Data and Statistics, Autism Spectrum Disorders, at http://www.cdc.gov/ncbddd/autism/data.html.
289
CIA World Factbook at https://www.cia.gov/library/publications/the-world-factbook/rankorder/2091rank.html.
290
See Gallagher & Goodman, supra note 17 on developmental disabilities and McDonald et al, supra note 17 on
asthma. The Vaccine Injury Table, supra note 165, indicates death as a possible sequela of vaccination.
291
The VICP has compensated claims for neurological and behavioral disorders. See, e.g., Bricker v. Sec'y of Dep't
of Health & Human Servs., 1995 U.S. Claims LEXIS 109 (Fed. Cl. 1995); Fuller v. Sec'y of Dep't of Health &
Human Servs., 1996 U.S. Claims LEXIS 17 (Fed. Cl. 1996); Cook v. Sec'y of Dep't of Health & Human Servs.,
2005 U.S. Claims LEXIS 297 (Fed. Cl. 2005). Parties have also alleged that vaccines have caused diabetes and
autism, but those claims have generally been denied compensation. See, e.g., Dieudonne v. Sec'y of Dep't of Health
& Human Servs., 1996 U.S. Claims LEXIS 202 (Fed. Cl. 1996) (denying compensation for diabetes claim); Meyers
v. Sec'y of Dep't of Health & Human Servs., 2006 U.S. Claims LEXIS 142 (Fed. Cl. 2006) (denying compensation
for diabetes claim); Cedillo v. Sec'y of Dep't of Health & Human Servs., 2010 U.S. App. LEXIS 17900 (Fed. Cir.
2010) (denying compensation for autism claim); Hazlehurst v. Sec'y of Dep't of Health & Human Servs., 604 F.3d
1343 (Fed. Cir. 2010) (denying compensation for autism claim).
40
IV.
Reinterpreting Jacobson and Amending the 1986 Law
Restoring the requirements of emergency and imminent harm to justify compulsion, as
Jacobson prescribed, would end some of THE state police power abuses that exist today. In all
non-emergency situations, children and adults should have the right to informed consent and the
right to sue manufacturers for vaccine injury.
Today’s childhood vaccination mandates against non-fatal, non-contagious and low
prevalence diseases do not comport with Jacobson. Furthermore, vaccination of children alone
cannot create or maintain herd immunity for the entire population, the justification for the
mandate in Jacobson in the first place. There is a troubling appearance that the vaccines
imposed exclusively on children today are not necessary, failing to meet the requirements of
Jacobson.
States compel vaccination for children that they do not compel for adults, raising the
question whether these mandates violate equal protection. While the Supreme Court in Zucht
upheld a mandate exclusively for children, the smallpox mandate at issue was radically different
than today’s context. Before Jacobson, courts found vaccination mandates to be unconstitutional
because of race discrimination.292 Because of the 1986 Law’s broad liability protections and
financial incentives for industry and doctors, there are reasons other than public health for ACIP
to include vaccines on its recommended list. “History supports the view that coercive laws have
largely targeted disadvantaged minorities.”293 Children are at least arguably a disadvantaged
minority with no direct political or judicial representation. In the first two years of life when
children are recommended to be vaccinated most, they literally cannot speak.294 Adults would
likely be unwilling to tolerate vaccination mandates similar to those the government imposes on
children. Indeed, adult healthcare workers in New York State, faced with the prospect of a
single compulsory H1N1 vaccine for employment in 2009, mounted a successful political and
legal challenge to overturn the mandate. 295
Several childhood vaccines in state mandates today, such as vaccines against hepatitis B,
human papilloma virus (HPV) and tetanus,296 are not rationally related to school attendance.
Hepatitis B is transmissible through intravenous needle exchange or sexual contact; HPV is
292
Wong Wai, 103 F. at 10.
Mariner et al, supra note 95, at 588.
294
Most vaccines are recommended for the first 15 months of life. Recommended Immunization Schedule for
Persons Aged 0 Through 6 Years – United States, 2010, http://www.cdc.gov/vaccines/recs/schedules/downloads/
child/2010/10_0-6yrs-schedule-pr.pdf.
295
A New York State judge in Albany issued a temporary restraining order suspending the regulation and the New
York health authorities then declined to seek further enforcement. See Anemona Hartocollis & Sewell Chan, Albany
Judge Blocks Vaccination Rule, N.Y. TIMES, Oct. 16, 2009, http://www.nytimes.com/ 2009/10/17/
nyregion/17vaccine.html.
296
For CDC descriptions of diseases and transmission of hepatitis B, see http://www.cdc.gov/hepatitis/B/index.htm;
for HPV, see http://www.cdc.gov/hpv/WhatIsHPV.html; for tetanus, see http://www.cdc.gov/vaccines/vpdvac/tetanus/in-short-both.htm#trans.
293
41
transmissible through heterosexual intercourse. These transmitting activities are not part of
school curricula. Tetanus is transmitted through deep wound punctures and is not contagious.
No child unvaccinated for tetanus poses any risk of contagious disease to another child.
In an imaginable judicial challenge today, a school-aged plaintiff might argue that certain
compulsory vaccines, including vaccines for hepatitis B, seasonal influenza, varicella, HPV and
tetanus, fail to meet Jacobson’s necessity test. These vaccines are not rationally related to school
(hepatitis B, HPV),297 or the disease is not contagious (tetanus),298 or the illness does not pose
fatal risks or imminent harm to the individual or society (varicella and seasonal influenza).299
Such an approach might substantially reduce a state’s vaccination mandates, eliminating certain
vaccines that have been added since 1986.
Alternatively, a child might argue that the sheer number of childhood compulsory
“unavoidably unsafe” vaccines is oppressive and argue that the 14th Amendment rights to due
process and equal protection require that individuals be able to refuse all vaccines except those
imposed in situations of emergency and imminent harm. In such a challenge, the absence of any
state mandates for any adult population might indicate that childhood mandates are
discriminatory and violate equal protection. While Zucht upheld a school mandate for children
alone, the 1922 context was radically different than the context today. A challenge today might
have the effect of either initiating compulsory state mandates for adults or transforming many
compulsory vaccinations into recommended ones.
A challenge might argue that outside of the vaccination context, courts have dramatically
circumscribed Jacobson’s application since 1905. While the Supreme Court used Jacobson in
1927 to justify forced sterilization of mentally retarded women as a valid exercise of the police
power, the Supreme Court struck down that application in 1978, finding a right to reproductive
liberty.300 Many critics now view that use of the police power to sterilize healthy women against
their will as a gross civil rights abuse. Courts have similarly circumscribed government-imposed
quarantine and military conscription, the police power to which Justice Harlan analogized the
vaccination power in Jacobson.301
297
Id.
Id.
299
For CDC description of varicella, see http://www.cdc.gov/vaccines/vpd-vac/varicella/in-short-adult.htm#desc
and for seasonal flu, see http://www.cdc.gov/flu/keyfacts.htm.
300
Buck v. Bell, 274 U.S. 200 (1927) (“The principle that sustains compulsory vaccination is broad enough to cover
cutting the Fallopian tubes. Three generations of imbeciles are enough.” (citing Jacobson, 197 U.S. 11)), overruled
by Griswold v. Connecticut, 381 U.S. 479 (1965); See also Mariner et al., supra note 95, at 584 (“With the Court’s
imprimatur of involuntary sterilization laws, more than 60,000 Americans, mostly poor women, were sterilized by
1978.”).
301
Mariner et al, supra note 95, at 586 on quarantine (“While it [the Supreme Court] has not decided a case that
involved isolation or quarantine for disease, it has held that civil commitment for mental illness is unconstitutional
unless a judge determines the person is dangerous by reason of a mental illness. Assuming, as most scholars do, that
the law governing commitment to a mental institution also applies to involuntary confinement for contagious
diseases, the government would have the burden of proving, by “clear and convincing evidence,” that the individual
actually has, or has been exposed to, a contagious disease and is likely to transmit the disease to others if not
298
42
A court would not need to overrule Jacobson; it would simply be required to examine
evidence of necessity and imminent harm. Few compulsory childhood vaccines today are
warding off infectious disease threats that would reach the high threshold Jacobson set. And
actual uptake of childhood vaccines might or might not change by reducing the number of
compulsory ones. Limiting compulsion would simply allow doctors and parents to make
individualized choices.
The right of philosophical exemption, or the right to refuse compulsory vaccination,
exists today by statute in 22 states. A majority of the U.S. population enjoys this right.302 Such a
right has existed by statute in the United Kingdom since 1898 and exists under constitutional law
in Canada, Australia, Scandinavia, Germany and several other developed countries.303 Some
countries, such as Japan, have no compulsory vaccination laws and achieve high rates of vaccine
uptake through persuasion alone.304 There is no evidence that jurisdictions with rights of
philosophical or religious exemption have higher burdens of infectious disease or less favorable
overall health outcomes.305
In addition to courts’ restoring Jacobson’s plain meaning, Congress should consider
revising the 1986 Law’s liability protections for manufacturers and doctors. The law has failed
to achieve its stated purposes to make vaccines safer and to compensate injured children
confined.”). For conscientious objection, Congress has allowed conscientious objection from military service since
1864 but required the objection to be based on religious belief. However, the Supreme Court has interpreted the
statute broadly, allowing that sincere objections “based on 'moral, ethical, or religious beliefs about what is right or
wrong'” fall within the definition of religion. Daniel A. Salmon & Andrew W. Siegel, Religious and Philosophical
Exemptions from Vaccination Requirements and Lessons Learned from Conscientious Objectors from Conscription,
116 PUB. HEALTH REPS. 289, 292 (July – Aug. 2001).
302
The following states have philosophical exemptions: Arizona, Arkansas, California, Colorado, Idaho, Louisiana,
Maine, Michigan, Minnesota, Missouri, New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Utah,
Vermont, Washington, and Wisconsin. See States With Religious and Philosophical Exemptions from School
Immunization Requirements, supra note 87.
303
There is no mandatory vaccination in the United Kingdom. Childhood Immunisation: A Guide for Healthcare
Professionals, BRIT. MED. ASS'N BD. OF SCI. & EDUC. (June 2003), http://www.bma.org.uk/images/childhoodimm
_tcm27-20002.pdf [hereinafter Childhood Immunisation]. Scandinavia and Germany also rely on voluntary
vaccination rather than compulsion. Id. There are some vaccination requirements in Australia, but there is a broad
right of conscientious objection. Salmon, supra note 100, at 438. Some provinces in Canada require vaccines but
allow conscientious objection, and the country as a whole does not mandate vaccination. Vaccine Safety FAQ, Pub.
Health Agency of Can. (April 14, 2008), http://www.phac-aspc.gc.ca/im/vs-sv/vs-faq16-eng.php.
304
Id., Childhood Immunisation at 5.
305
For example, in 2008, the United Kingdom with a population of roughly 61 million, had five reported cases of
diphtheria, 1,445 reported cases of measles, and 2,625 reported cases of mumps. Immunization Profile – United
Kingdom of Great Britain and Ireland, World Health Organization, http://apps.who.int/immunization_monitoring/
en/globalsummary/countryprofileresult.cfm?C='gbr'. Similarly, in 2008 Australia had a population of roughly 21
million and had zero reported cases of diphtheria, 65 reported cases of measles, and 286 reported cases of mumps.
Immunization Profile – Australia, World Health Organization, http://apps.who.int/immunization_
monitoring/en/globalsummary/countryprofileresult.cfm?C='aus'. In the United States, where choice is more limited,
in 2008 with a population of roughly 311 million, there were zero reported cases of diphtheria, 43 reported cases of
measles, and 800 reported cases of mumps. Immunization Profile – United States of America (Aug. 3, 2010).
43
generously and swiftly.306 By making the VICP optional, Congress might make the tax-financed
compensation system work. If families had the choice to file claims in civil courts or in the
VICP, industry and doctors would have strong financial incentives to make the VICP as
petitioner-friendly as possible, providing quick, generous, administrative compensation.
Industry and doctors then would have incentives to put all recognized vaccine-related injuries on
the Vaccine Injury Table to induce families to take their claims there rather than the tort system.
Manufacturers would still be able to substantially limit their liability by making the VICP a
better alternative than tort litigation in civil court, as Congress intended.
Congress should also consider repealing the 1986 Law’s provisions which abrogate the
right to proper warnings. It is troubling that the nation’s most vulnerable population is deprived
of accurate and complete information, unlike any other civilian group. Reinstating manufacturer
and medical liability and the requirement of proper warnings would restore the safety incentives
that the 1986 Law improvidently removed.
CONCLUSION
In true emergencies of epidemic disease that threaten an entire population, such as
smallpox or anthrax, states have the right and responsibility to adopt measures to address them.
Jacobson and Zucht upheld vaccination mandates for adults and children in this context. In nonemergency situations, however, as predominantly exist today, compulsory vaccination mandates
exclusively for children are unreasonable and oppressive and have led to the perverse results of
which Jacobson warned. Giving effect to Jacobson’s plain meaning and amending the 1986
Law would restore the ordinary tort law protections of informed consent and the right to sue.
Such a move away from compulsion would restore children’s rights and better protect their
health and safety.
306
See Brief of Vaccine Injured Petitioners Bar Association, supra note 160, at 7.
44
Compulsory Vaccination, the Constitution, and the
Hepatitis B Mandate for Infants and Young Children
Mary Holland*
INTRODUCTION .................................................................................................. 41
I. PUBLIC HEALTH LAW .................................................................................... 42
A. JUDICIAL DECISIONS BEFORE JACOBSON V. MASSACHUSETTS .................. 42
B. JACOBSON V. MASSACHUSETTS .................................................................. 44
1. CONSTITUTIONAL STANDARDS OF REVIEW ............................................. 48
2. JACOBSON’S EARLY LEGACY .................................................................. 49
3. ZUCHT V. KING: JACOBSON’S LEGACY FOR SCHOOL CHILDREN ............ 50
4. THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) ..... 54
5. THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986 (NCVIA) . 55
II. THE SUPREME COURT’S PERSONAL AUTONOMY JURISPRUDENCE .......... 59
A. FORCED STERILIZATION, CONTRACEPTION AND ABORTION ...................... 59
B. THE RIGHT TO MAKE MEDICAL TREATMENT DECISIONS........................... 61
C. THE RIGHT TO AUTONOMY IN SEXUAL RELATIONS ................................... 64
III. A HYPOTHETICAL CHALLENGE TO A HEPATITIS B VACCINATION
MANDATE FOR PRESCHOOL CHILDREN .............................................. 66
A. HEPATITIS B DISEASE, FEDERAL POLICY, VACCINATION MANDATES AND
PUBLIC RESPONSE ........................................................................................... 67
1. THE 1982 AND 1988 ACIP RECOMMENDATIONS ..................................... 68
2. THE 1991 ACIP RECOMMENDATION ....................................................... 69
3. THE 1999 ACIP RECOMMENDATION ....................................................... 72
4. THE 2005 ACIP RECOMMENDATION ....................................................... 73
B. FINANCIAL CONSIDERATIONS IN HEPATITIS B VACCINATION MANDATES 76
* Research Scholar and Director, Graduate Legal Skills Program, NYU School of Law. I am
grateful to Heather Groves, Natalie Murphy, Michael Sexton, and Todd Rosenbaum for invaluable
research assistance. I am also grateful to Kevin Barry, Louis Conte, Louise Kuo Habakus, James
Holland, Jenny Roberts, Kim Mack Rosenberg, Juliet Stumpf, Edward Yazbak, the NYU
Lawyering Colloquium, and the Journal’s peer reviewers and staff for constructive critique.
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C. INFORMED CONSENT, OR LACK THEREOF, TO HEPATITIS B VACCINATION 79
D. A HYPOTHETICAL CHALLENGE TO THE NEW YORK STATE HEPATITIS B
VACCINE MANDATE FOR PRESCHOOLERS ....................................................... 80
1. PUBLIC HEALTH NECESSITY .................................................................... 80
2. REASONABLE MEANS .............................................................................. 81
3. PROPORTIONALITY................................................................................... 81
4. HARM AVOIDANCE .................................................................................. 82
5. NON-DISCRIMINATION ............................................................................. 82
6. LIBERTY INTEREST IN DUE PROCESS ....................................................... 82
7. LIBERTY INTEREST IN EQUAL PROTECTION ............................................ 84
CONCLUSION ...................................................................................................... 85
40
COMPULSORY VACCINATION
INTRODUCTION
The federal government today recommends that all children between birth
1
and age eighteen years receive seventy doses of sixteen vaccines. Of these
recommended vaccines, the majority of states mandate between thirty and forty2
five vaccine doses for children to be able to attend school. Forty-seven states
require preschool-age children to receive three doses of the hepatitis B vaccine to
3
attend public school. The federal government recommends that infants receive
their first dose of the hepatitis B vaccine shortly after birth, while they are in the
4
hospital.
The disease hepatitis B today affects approximately 730,000 people in the
5
United States. Hepatitis B is usually a chronic disease for which there is no
6
known cure; it can lead to severe liver disease and death. People spread the
disease through intimate contact, primarily through sex and shared intravenous
7
drug use. The vaccine has demonstrated efficacy in checking the spread of the
8
disease among the at risk population.
So what is the medical rationale for the hepatitis B vaccination mandate for
1. Recommended Immunization Schedule for Persons Aged 0 Through 6 Years—United States,
2011, CENTERS FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/vaccines/recs/schedules/
downloads/child/0-6yrs-schedule-bw.pdf (last visited Nov. 9, 2011); Recommended Immunization
Schedule for Persons Aged 7 Through 18 Years—United States, 2011, CENTERS FOR DISEASE
CONTROL & PREVENTION, http://www.cdc.gov/vaccines/recs/schedules/downloads/child/7-18yrsschedule-pr.pdf (last visited Nov. 28, 2011).
2. See Hepatitis B Prevention Mandates for Daycare and K-12, IMMUNIZATION ACTION
COALITION, http://www.immunize.org/laws (last updated May 26, 2011) (showing vaccination
mandates by state). While the Coalition is solely responsible for the website, its information is
based on government sources, and the website is funded in part by the Centers for Disease Control
and Prevention.
3. Id. (showing that only Alabama, Montana, and South Dakota have no hepatitis B mandates
for daycare or school).
4. Ctrs. for Disease Control & Prevention, A Comprehensive Immunization Strategy To
Eliminate Transmission of Hepatitis B Virus Infection in the United States: Recommendations of
the Advisory Committee on Immunization Practices (ACIP) Part I: Immunization of Infants,
Children and Adolescents, 54 MORBIDITY & MORTALITY WKLY. REP., Dec. 23, 2005, at 1, 15,
available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm.
5. Annemarie Wasley et al., The Prevalence of Hepatitis B Virus Infection in the United States
in the Era of Vaccination, 202 J. INFECTIOUS DISEASES 192 (2010).
6. Hepatitis B Information for the Public, CENTERS FOR DISEASE CONTROL & PREVENTION,
http://www.cdc.gov/hepatitis/B (last updated Mar. 12, 2009).
7. Ctrs. for Disease Control & Prevention, supra note 4.
8. Ctrs. for Disease Control & Prevention, Hepatitis B Virus: A Comprehensive Strategy for
Eliminating Transmission in the United States Through Universal Childhood Vaccination:
Recommendations of the Immunization Practices Advisory Committee (ACIP), 40 MORBIDITY &
MORTALITY WKLY. REP., Nov. 22, 1991, at 1, 2, available at http://www.cdc.gov/mmwr/preview/
mmwrhtml/00033405.htm.
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very young children? What legal requirements must a state meet to enable it to
impose such a mandate? To what extent have the legal requirements for
vaccination mandates changed over time? Do states today meet the constitutional
requirements for the hepatitis B vaccination mandate for very young children?
These are the questions that this Article explores.
The Article highlights the historical requirements for vaccination mandates:
necessity, reasonable means, proportionality, non-discrimination, harm
avoidance, and fairness. It considers Fourteenth Amendment Due Process and
Equal Protection Clause requirements. It shows that the vaccination mandate that
the Supreme Court upheld in 1905 was markedly different from today’s hepatitis
9
B mandate for preschoolers. The Jacobson decision upheld a mandate for the
entire population, in the context of an airborne epidemic emergency, with a
relatively small monetary fine for non-compliance. Today’s hepatitis B mandate
is imposed exclusively on children, for preventive purposes, although children
are at minimal risk of contracting the disease—a disease that is transmitted
exclusively through intimate contact—on penalty of limiting the right to an
education.
The Article is divided into three Parts. Part I reviews public health law
related to vaccination, including Jacobson v. Massachusetts; the public health
mechanism to recommend vaccination mandates; and the Congressional statute
that created the federal vaccine program. Part II considers more recent Supreme
Court precedent on personal autonomy, addressing rights in bodily integrity and
medical decision-making. Part III considers a hypothetical challenge to New
York State’s hepatitis B vaccination mandate for preschool children. Part III also
considers the evolution of federal hepatitis B recommendations, financial
considerations in mandates, vaccine safety, informed consent, and the manner in
which the Supreme Court might review a challenge. The Article concludes that
the constitutionality of state vaccination mandates against hepatitis B disease for
preschool children is questionable.
I. PUBLIC HEALTH LAW
A. Judicial Decisions Before Jacobson v. Massachusetts
Infectious diseases were leading causes of death in the United States until
the 20th century. During the 19th century, movement from the countryside to
cities, with overcrowded housing, inadequate sanitation and impure drinking
10
water, spurred outbreaks of infectious disease. These conditions resulted in
repeated epidemics of cholera, typhoid, influenza, and malaria. In 1900, more
9. Jacobson v. Massachusetts, 197 U.S. 11 (1905).
10. Ctrs. for Disease Control & Prevention, Achievements in Public Health, 1900-1999:
Control of Infectious Diseases, 48 MORBIDITY & MORTALITY WKLY. REP. 621, 622 (1999),
available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4829a1.htm.
42
COMPULSORY VACCINATION
than thirty percent of all deaths occurred among children under five years of
11
age. Although vaccination carried recognized risks, the practice became
widespread in Europe and the United States in the 1800s as a preventive health
12
measure against smallpox, a deadly, contagious, airborne disease. In the 19th
century, vaccination against smallpox meant introducing a milder form of the
disease, cowpox, into individuals and inducing an immune response intended to
prevent the recipient from getting smallpox. If a vaccination subject received a
sufficiently strong immune response, he would not contract smallpox over
13
several years, even if repeatedly exposed to it. Compulsory smallpox
vaccination was introduced in some jurisdictions in the 1800s to ensure “herd
immunity.” When a large proportion of a community is vaccinated, these
individuals form a barrier which prevents spread of the disease to those not
vaccinated and those for whom the vaccine is ineffective. The proportion
required for “herd immunity” varies depending on the infectious agent. For polio,
14
the proportion is about eighty percent; for measles, it is above ninety percent.
Vaccination mandates are laws requiring individuals to be vaccinated or face
penalties, such as a fine or deprivation of the right to attend school. Before
Jacobson, state statutes on vaccination varied. In 1905, eleven states had
compulsory vaccination mandates for smallpox, but the majority, thirty-four
states, did not. No states had, or have, laws that force vaccination on unwilling
subjects. In other words, no states physically restrain and vaccinate individuals,
15
although this practice reportedly has occurred.
Judicial decisions interpreting state laws on vaccination before Jacobson
were similarly diverse. In 1894, the Pennsylvania Supreme Court upheld the right
of the state to exclude unvaccinated children from school during a smallpox
epidemic, but took pains to point out that the state could not physically force
vaccination. It simply upheld the regulation to exclude unvaccinated children to
16
protect the public health during an epidemic. In 1900, the Utah Supreme Court
11. Id. at 621.
12. Jacobson, 197 U.S. at 34 (“Smallpox is known of all to be a dangerous and contagious
disease.” (quoting Viemeister v. White, 72 N.E 97, 99 (N.Y. 1903))).
13. Id.
14. LAW IN PUBLIC HEALTH PRACTICE 340 (Richard A. Goodman et al. eds., 2003); see also
Steve P. Calandrillo, Vanishing Vaccinations: Why Are So Many Americans Opting Out of
Vaccinating Their Children?, 37 U. MICH. J.L. REFORM 353, 419-21 (2004) (describing herd
immunity); Gail Javitt et al., Assessing Mandatory HPV Vaccination: Who Should Call the Shots?,
36 J.L. MED. & ETHICS 384, 388 (2008) (describing the theory of herd immunity, which postulates
that, as vaccination rates rise, chains of communicable disease transmission are interrupted and
diseases—and the risks they present to the public health—can be eliminated altogether).
15. See e.g., Michael Willrich, “The Least Vaccinated of Any Civilized Country”: Personal
Liberty and Public Health in the Progressive Era, 20 J. POL’Y HIST. 76, 85-86 (2008) (“The local
health authorities carried out the orders during a public health emergency, and their impatience
with resistance led easily to violence, including many documented cases of physical-force
vaccination.”).
16. Duffield v. Williamsport Sch. Dist., 29 A. 742 (Pa. 1894).
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similarly upheld an exclusion order for an unvaccinated child, but this majority
opinion prompted a strong dissent, noting that the exclusion rule was “an attempt,
indirectly, to make vaccination compulsory” and that the medical board had no
17
such authority. In 1902, the Minnesota Supreme Court upheld a school
exclusion rule for an unvaccinated child, but made clear that its ruling was
18
narrow and permissible “in cases of emergency only.” In 1900, a California
court established that no vaccination mandate could be applied in a racially
discriminatory manner because it would violate the equal protection clause of the
19
Fourteenth Amendment to the Constitution.
In 1903, New York’s highest court opined that the state’s mandate for school
vaccination and its state constitutional right to a public education were
compatible provisions. It construed the state constitution’s language, “[t]he
Legislature shall provide for the maintenance and support of a system of free
common schools, wherein all the children of this State may be educated,” as a
20
privilege, not a right. It reasoned that because all pupils were subject to the
same vaccination obligation, the state met constitutional due process and equal
protection guarantees. It further suggested that courts owe great deference to
legislatures on such questions. It relied on decisions of several other courts that
found that state constitutional guarantees of education did not contradict
21
vaccination mandates, even when there was no imminent threat of disease.
While judicial decisions preceding Jacobson never forced vaccination, they
often justified existing mandates, whether for adults or children, and upheld
exclusion of unvaccinated children from public school during epidemics. Some
courts spoke explicitly of the need to show necessity and emergency; others took
a more expansive view, leaving broad discretion to the legislatures on matters of
public health. In short, there was an emerging judicial consensus to uphold
vaccination mandates, but the overwhelming majority of states did not impose
them. And, in any event, at issue was always a single vaccine against one disease.
B. Jacobson v. Massachusetts
22
Today there are school vaccination laws in fifty states and mandates for
23
certain categories of adults, such as military personnel and healthcare
17. State ex rel. Cox v. Bd. of Educ., 60 P. 1013, 1020 (Utah 1900).
18. Freeman v. Zimmerman, 90 N.W. 783, 784 (Minn. 1902).
19. Wong Wai v. Williamson, 103 F. 1 (N.D. Cal. 1900).
20. Viemeister v. White, 84 N.Y.S. 712, 713 (App. Div. 1903).
21. Id. at 718.
22. James G. Hodge, Jr. & Lawrence O. Gostin, School Vaccination Requirements: Historical,
Social, and Legal Perspectives, 90 KY. L.J. 831, 833 (2002) (“Each state has school vaccination
laws which require children of appropriate age to be vaccinated for several communicable
diseases.”).
23. Military regulations require U.S. soldiers to be vaccinated against a number of diseases,
including hepatitis A, influenza, tetanus, diphtheria, measles, mumps, rubella, polio, and yellow
44
COMPULSORY VACCINATION
24
workers. There are also public health acts for emergencies with vaccination
25
provisions in many states. In 1905, the Supreme Court in Jacobson decided that
states may impose reasonable regulations to ensure the public health and safety,
even if such regulations infringe individuals’ personal liberty.
Jacobson came to the United States Supreme Court from the Massachusetts
Supreme Court, which upheld the validity of a Cambridge, Massachusetts
mandate to compel smallpox vaccination for all adults on penalty of a five-dollar
26
fine (the equivalent of about $110 today). Mr. Jacobson refused to comply with
the regulation and would agree neither to be vaccinated nor pay the five-dollar
fine. Mr. Jacobson argued that the regulation violated his rights under the Fifth
27
and Fourteenth Amendments. He argued that the state mandate threatened his
life, liberty, and property, and deprived him of the due process and equal
protection of the law. In essence, he argued that his right to bodily integrity and
personal liberty trumped the state’s right to impose vaccination in the name of
public health.
In upholding the Cambridge regulation, the Supreme Court reasoned that
constitutional protection of individuals is not unlimited and that states retain
police powers to ensure public health and safety. States retain the right to issue
reasonable regulations, it argued, and, in the context of a potential smallpox
epidemic, Cambridge’s ordinance was not “unreasonable, arbitrary and
28
oppressive.” It was the legitimate province of the elected legislature to decide
what measures would be best, and the legislature was unquestionably aware of
opposing views about vaccination among the medical profession and the
fever. See PETER J. SCHOOMAKER ET AL., ARMY REGULATION 40-562, IMMUNIZATIONS AND
CHEMOPROPHYLAXIS (2006), available at http://www.vaccines.mil/documents/969r40_562.pdf.
24. The CDC provides information on states’ requirements for healthcare workers and
patients. Vaccines & Immunizations: State Immunization Laws for Healthcare Workers and
Patients, CENTERS FOR DISEASE CONTROL & PREVENTION, http://www2a.cdc.gov/nip/
StateVaccApp/statevaccsApp/default.asp (last modified Sept. 19, 2011). For instance, in New
York, hospital employees must be offered hepatitis B vaccine and are required to be vaccinated
against measles, mumps, and rubella. Vaccines & Immunizations: Immunization Administration
Requirements for State: NY, CENTERS FOR DISEASE CONTROL AND PREVENTION,
http://www2a.cdc.gov/nip/StateVaccApp/statevaccsApp/Administration.asp?statetmp=NY
(last
modified Sept. 19, 2011).
25. See JAMES G. HODGE, JR. & LAWRENCE O. GOSTIN, THE MODEL STATE EMERGENCY
HEALTH POWERS ACT - A BRIEF COMMENTARY (2002), available at http://www.publichealthlaw.
net/MSEHPA/Center%20MSEHPA%20Commentary.pdf.
26. The Consumer Price Index was started in 1913 to track changes in prices of consumer
goods. A government inflation calculator indicates that $5 in 1913 would be the same as about
$114.59 in 2011. CPI Inflation Calculator, BUREAU LABOR STAT., http://www.bls.gov/data/
inflation_calculator.htm (last visited Nov. 9, 2011).
27. See U.S. CONST. amend. XIV, § 1 (“No state shall make or enforce any law which shall
abridge the privileges or immunities of citizens of the United States; nor shall any state deprive any
person of life, liberty, or property, without due process of law; nor deny to any person within its
jurisdiction the equal protection of the laws.”).
28. Jacobson v. Massachusetts, 197 U.S. 11, 26 (1905).
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electorate. The regulation required the inhabitants to be vaccinated only when
29
“that was necessary for the public health or the public safety.” The regulation
did not violate the Fourteenth Amendment because it was “applicable equally to
30
all in like condition.” The Court analogized the state’s police power to impose a
vaccination mandate to its power to enforce quarantines and to the federal
31
government’s right to impose a military draft.
Jacobson’s claims arose under the Fourteenth Amendment’s Due Process
and Equal Protection clauses, but the decision makes no mention of substantive
due process under the Fourteenth Amendment. Only two months later, the Court
32
articulated that doctrine in the Lochner decision. Lawrence Gostin, a public
health law authority, cited Jacobson for the proposition that public health
regulations require five elements to be constitutional: (1) public health necessity,
33
(2) reasonable means, (3) proportionality, (4) harm avoidance, and (5) fairness.
In trying to square Jacobson with Lochner, a recent commentator, Dr. Allan
Jacobs, argued that “[t]he Court’s proscription of ‘arbitrary and oppressive’ state
action may be invoking procedural due process in banning ‘arbitrary’ action, and
34
substantive due process in proscribing ‘oppressive’ action.”
However, the Court did not give states blind deference. It justified the
Cambridge regulation as reasonable, recognizing that it imposed one vaccine, on
the entire adult population, in the context of a contagious, deadly epidemic, with
a relatively small fine for non-compliance. The regulation excluded some
children from compliance. The Court’s paradigm was clear: a mandate is
35
36
permissible in “an emergency,” when there was “imminent danger,” when
37
“an epidemic of disease . . . threatens the safety of [society’s] members,” when
38
there was “the pressure of great dangers,” and for an “epidemic that imperiled
39
The Court’s language–emergency, imminent danger,
an entire population.”
peril to the entire population–suggests grave risk. While Professor Shapiro in his
response downplays this high threshold, I believe Justice Harlan’s words speak
for themselves.
Describing the potential abuse of police power, the Court opined:
29. Id. at 27.
30. Id. at 30.
31. Id. at 29-30.
32. Lochner v. New York, 198 U.S. 45 (1905) (striking down a state public health regulation
as a restriction on the substantive due process right to freedom of contract).
33. LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 126-28 (2d ed.
2008).
34. Allan J. Jacobs, Needles and Notebooks: The Limits of Requiring Immunization for School
Attendance, 33 HAMLINE L. REV. 171, 183 (2010) (discussing Jacobson v. Massachusetts).
35. Jacobson, 197 U.S. at 27.
36. Id. at 29.
37. Id. at 27.
38. Id. at 29.
39. Id. at 31.
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[A regulation] might be exercised in particular circumstances
and in reference to particular persons in such an arbitrary,
unreasonable manner, or might go so far beyond what was
reasonably required for the safety of the public, as to authorize or
compel the courts to interfere for the protection of such
persons.40
The Court noted cases when state laws “went beyond the necessity of the case,
and, under the guise of exerting a police power . . . violated rights secured by the
41
Constitution.” It stated:
There is, of course, a sphere within which the individual may
assert the supremacy of his own will, and rightfully dispute the
authority of any human government, especially of any free
government existing under a written constitution, to interfere
with the exercise of that will.42
The Court cautioned that if a state statute purported to be for the public
health, but “has no real or substantial relation to those objects, or is, beyond all
question, a plain, palpable invasion of rights secured by the fundamental law, it is
43
the duty of the courts to so adjudge.” The Court anticipated that the police
power to vaccinate might include circumstances when regulations could be “so
arbitrary and oppressive . . . as to justify the interference of the courts to prevent
44
wrong and oppression.”
The Court expressly created a medical exemption from vaccination, when a
person was not a fit subject for vaccination and it “would be cruel and inhuman
45
in the last degree” to vaccinate him. Because of Jacobson, medical exemptions
46
exist in all fifty states. Although the Jacobson decision did not create them,
47
and
statutory religious exemptions exist in forty-eight states today,
philosophical or conscientious belief exemptions exist by statute in twenty
48
states.
40. Id. at 28 (citing Wis., Minn. & Pac. R.R. v. Jacobson, 179 U.S. 287 (1900)).
41. Id.
42. Id. at 29.
43. Id. at 31.
44. Id. at 38.
45. Id. at 39.
46. Hodge & Gostin, supra note 22, at 874 (“While the statutory provisions vary from state to
state, all school immunization laws grant exemptions to children with medical contra-indications to
immunization, consistent with the judicial and ethical principles of harm avoidance asserted by the
Supreme Court in Jacobson v. Massachusetts.”).
47. See States with Religious and Philosophical Exemptions from School Immunization
Requirements, NAT’L CONF. ST. LEGISLATURES (Mar. 2011), http://www.ncsl.org/default.aspx?
tabid=14376 (only West Virginia and Mississippi do not have religious exemptions).
48. Id. Under a philosophical exemption, a person need not specify the basis for her objection
to vaccination.
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Although the Court was clearly wary of treading on areas of legislative
competence, it proclaimed the right, indeed the responsibility, to give sensible
construction to any regulation so that it would not lead to “injustice, oppression,
49
or an absurd consequence.” It made clear that no law should be interpreted in
50
practice to be “cruel and inhuman in the last degree.”
1. Constitutional Standards of Review
It is not certain what standard of review the Supreme Court would apply to a
state compulsory vaccination mandate today. The Supreme Court decided
Jacobson before it had adopted explicit standards for review of government
authority. In Jacobson, the Court required only that Massachusetts’s statute be
rationally related to the purpose of eradicating infectious disease. Since the
1940s, however, as Part II explores, the Court has held that a higher standard
51
must apply if a state law impinges on a fundamental liberty interest. For a law
to be constitutional under a strict scrutiny test, the highest standard, there must be
a compelling governmental interest and the law must be narrowly tailored to
achieve its end.52 In cases where strict scrutiny does not apply, the Supreme
Court usually uses the lowest standard, the rational basis test. The rational basis
test applies when the rights at stake are not considered fundamental. Under this
standard of review, “if a law neither burdens a fundamental right nor targets a
suspect class, we will uphold the [law] so long as it bears a rational relation to
some legitimate end.”53
Between these two extremes of strict scrutiny and rational basis review, the
Supreme Court has required an intermediate level of scrutiny or a “pumped-up”
rational basis test for liberty interests after Jacobson.54 In these cases, the
Supreme Court has struck down questionable state laws on the grounds that the
state interest did not outweigh an individual’s liberty interest. Several prominent
public health scholars have suggested that a case like Jacobson today would
require intermediate scrutiny because of the clear liberty interests at stake. 55
In recent decisions, the Supreme Court has itself read Jacobson to support
the inference that the Constitution protects a patient’s liberty interest in the right
49. Jacobson, 197 U.S. at 39.
50. Id.
51. See infra Part II.
52. Id.
53. Romer v. Evans, 517 U.S. 620, 631 (1996).
54. City of Cleburne Texas v. Cleburne Living Center, 473 U.S. 432 (1985).
55. GOSTIN, supra note 33, at 141 (“The Court has found a constitutionally protected liberty
interest in bodily integrity, but it has yet to hold that such an interest is ‘fundamental.’”); KENNETH
R. WING & BENJAMIN GILBERT, THE LAW AND THE PUBLIC’S HEALTH 24 (7th ed. 2007) (“[I]f
Lochner or Jacobson were argued today, the analysis in both cases would likely adopt the “rational
basis/close scrutiny” rhetoric that modern courts have developed in the last several decades . . . .”).
48
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56
to refuse care, suggesting that it would apply intermediate scrutiny. The Court
has found that “[t]he forcible injection of medication into a nonconsenting
person's body represents a substantial interference with that person's liberty.”57
2. Jacobson’s Early Legacy
Initial interpretation of Jacobson was circumspect. From 1907 to 1914, state
appellate and supreme courts construed Jacobson as permitting single
58
vaccination mandates during smallpox outbreaks. The courts upheld mandates
and exclusion of unvaccinated school children during emergencies. These
decisions applied an “oppressive or arbitrary” standard and looked for evidence
59
of public necessity, and, particularly, the threat of epidemic. These decisions
60
held that statutes must incorporate medical exemptions. The decisions required
that school boards act in good faith and exclude unvaccinated students only as
61
long as the danger of smallpox endured.
Beginning in 1916, however, judicial interpretations of Jacobson broadened.
The Alabama Supreme Court read Jacobson to contain the implied power to
prevent epidemics, not simply to respond to existing ones. A father sued the
school board for excluding his unvaccinated daughter from school when there
62
was no smallpox epidemic. The court upheld the state’s delegation of authority
to the school board and the state’s right to prevent disease. The decision also
argued that mandates for children, and not adults, were valid because a group of
children “constitutes a condition different, with respect to hygienic
circumstances, effects, and results, from that to be found in any other character of
63
assemblage in a municipality.” The court deferred to municipal authorities on
64
public health.
The Kentucky Supreme Court reached a similar conclusion that same year,
finding that boards “are not required to wait until an epidemic actually exists
before taking action. Indeed, one of the chief purposes of their existence is to
65
adopt and enforce such timely measures as will prevent epidemics.” These
decisions interpreted Jacobson expansively; in neither situation was there an
56. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 278 (1990).
57. Washington v. Harper, 494 U.S. 210, 229 (1990).
58. Hammond v. Town of Hyde Park, 80 N.E. 650 (Mass. 1907); State ex rel. O’Bannon v.
Cole, 119 S.W. 424 (Mo. 1909); People v. Ekerold, 105 N.E. 670 (N.Y. 1914); McSween v. Bd. of
Sch. Trs., 129 S.W. 206 (Tex. Civ. App. 1910); State ex rel. McFadden v. Shorrock, 104 P. 214
(Wash. 1909).
59. O’Bannon, 119 S.W. at 427.
60. McFadden, 104 P. at 216.
61. Hammond, 80 N.E. at 651.
62. Herbert v. Demopolis Sch. Bd. of Educ., 73 So. 321 (Ala. 1916).
63. Id. at 323.
64. Id.
65. Bd. of Trs. v. McMurtry, 184 S.W. 390, 394 (Ky. 1916).
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imminent danger or necessity for the state to act in self-defense.
3. Zucht v. King: Jacobson’s Legacy for School Children
All states today compel elementary education, whether in public or private
schools or at home. States compel education under the police power and under
the state’s role as parens patriae, or protector of the state. The Supreme Court’s
decision in Wisconsin v. Yoder acknowledged that compulsory “education is
necessary to prepare citizens to participate effectively and intelligently in our
66
open political system.” Since 1943, the Supreme Court has recognized that “the
state as parens patriae may restrict the parent’s control by requiring school
67
attendance.”
In 1922, the Supreme Court held in Zucht v. King that a smallpox
vaccination mandate for school admission was a valid exercise of the police
68
power. In a cursory, unanimous decision, the Court cited Jacobson as settling
69
that compulsory vaccination may be a requirement of public school admission.
Denying the petitioner’s claim of infringement of her Fifth and Fourteenth
70
Amendment rights based on Jacobson, the Court did consider that the law
71
might have been administered in a way that violated her rights. Nonetheless,
the Court found that the school vaccination mandate had not conferred arbitrary
power, but “only that broad discretion required for the protection of the public
72
health.” It did not inquire into the circumstances of the epidemic and affirmed
substantial deference to the school board, with smallpox as the relevant, but
unnamed, backdrop.
Zucht did not alter Jacobson’s analysis that necessity is required to justify
state police powers, but it applied this analysis outside of a mandate for the
whole population. Whether the Justices thought that Jacobson’s analysis was
sufficient or that smallpox posed an obvious risk, the Supreme Court affirmed the
mandate without detailed discussion. Indeed, Zucht is a three paragraph decision
presumably intended to stop judicial challenges to school smallpox vaccination
mandates.
Zucht did shift Jacobson’s paradigm, though, by upholding a mandate
exclusively for children, a subpopulation, and by affirming the validity of a
preventive mandate for a disease not in circulation. It is notable that the
Cambridge regulation in Jacobson specifically excluded some children as
excessively vulnerable subjects for compulsory vaccination with the smallpox
66. Wisconsin v. Yoder, 406 U.S. 205, 221 (1972).
67. Prince v. Massachusetts, 321 U.S. 158, 166 (1943).
68. Zucht v. King, 260 U.S. 174, 176 (1922).
69. Id. at 176.
70. Id.
71. Id. at 177.
72. Id.
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73
vaccine. Zucht did not acknowledge that there might be an equal protection
problem if the mandate was imposed selectively on children rather than the
74
population as a whole. Still, Zucht did not lessen Jacobson’s requirements to
75
compel vaccination.
Zucht implicitly acknowledged that school attendance creates unique threats
to the health of the children gathered there. Hundreds, or even thousands, of
children may be in one building for several hours a day, making transmission of
airborne disease likely. As Dr. Allan Jacobs noted:
A public health necessity exists when the disease is serious and
vaccination to obtain herd immunity is substantially safer than
failure to vaccinate. The reasonable means test is satisfied by the
nexus between school attendance and disease transmission. The
proportionality test is satisfied by the relative safety of the
vaccine. Finally, the principle of harm avoidance is met by
allowing exemption for medical conditions that make
vaccination detrimental to a child’s health.76
Jacobson requires that decisions to mandate vaccination for school
attendance be subject to a balancing test that assesses the severity of the disease,
the risks of the vaccine, the amount of overall clinical experience with the
vaccine, and alternative methods of prevention. As Dr. Jacobs suggested, “The
absence of linkage of a disease to school activities should weigh heavily against a
77
vaccination requirement.”
Some commentators reject the view that there must be a close nexus between
78
school and vaccination to warrant a state mandate. Indeed, states do impose
vaccines on school children for tetanus, a noncontagious disease, and for
relatively mild childhood illnesses, such as rubella, largely to protect pregnant
mothers from infection. One expert sees such mandates as instrumental in
furthering “society’s strong interest in ensuring that people are protected from
73. Jacobson v. Massachusetts, 197 U.S. 11, 30 (1905) (“[T]here are obviously reasons why
regulations may be appropriate for adults which could not be safely applied to persons of tender
years.”).
74. Id.
75. Zucht raises some procedural problems in interpretation. The writ of error was dismissed
because of the lack of a federal question. Justice Brandeis noted at the end of the opinion that some
of the issues the case raised would only be appropriate before the Court on a writ of certiorari, not
a writ of error. This may help to explain why this critically important decision on childhood
vaccination is so cursory.
76. Jacobs, supra note 34, at 192-93.
77. Id. at 193.
78. Scholars favoring the human papilloma virus vaccine mandate hold this view. See, e.g.,
Cynthia Dailard, Achieving Universal Vaccination Against Cervical Cancer in the United States:
The Need and the Means, 9 GUTTMACHER POL’Y REV. 12 (2006); Sylvia Law, Human
Papillomavirus Vaccination, Private Choice, and Public Health, 41 U.C. DAVIS L. REV. 1731
(2008).
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79
disease throughout their lives.” Others suggest that vaccination mandates can
realistically only be for children because “no national program exists to support
vaccine purchase and infrastructure for vaccine delivery to uninsured and
80
underinsured adults.” As a matter of constitutional law, unresolved questions
remain about which criteria are essential for valid vaccination mandates.
81
By 1934, courts read Jacobson to validate preventive smallpox mandates.
The Mississippi Supreme Court granted discretion to public health authorities,
stating “the presumption is in favor of the reasonableness and propriety of
82
regulations enacted in pursuance of such grant of power.” A 1934 Texas court
83
decided that it could not evaluate whether an emergency existed. It explained,
“[W]e cannot attempt to measure how pressing a necessity must be in order to
84
allow the board’s discretion to be exercised.” That court flatly rejected the idea
85
that the court could assess emergency.
Courts increasingly deferred to states’ police powers in the ensuing years. In
1948, the New Jersey Supreme Court, upholding a school vaccination mandate,
held that “the question of the desirability or efficacy of compulsory vaccination
and whether it is wise or unwise is strictly a legislative and not a judicial
86
question.” The Court seemed to read Jacobson to justify all vaccination
mandates, disregarding its language to reject unreasonable, arbitrary or
87
oppressive state actions.
A 1951 Arkansas case asked the court to evaluate the validity of a preventive
school vaccination mandate, but that court decided that it was not its place to
88
judge the efficacy or safety of vaccinations. The court even suggested that the
plaintiffs should lodge objections with the Board of Health rather than the
89
court.
By the mid-1950s, it was arguably settled law that school vaccination
mandates were presumptively valid. Jacobson’s cautionary language had not
figured meaningfully into the case’s application. In 1964, the Arkansas Supreme
79. Dailard, supra note 78, at 14.
80. Eric E. Mast et al., Ctrs. for Disease Control & Prevention, A Comprehensive
Immunization Strategy To Eliminate Transmission of Hepatitis B Virus Infection in the United
States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II:
Immunization of Adults, 55 MORBIDITY & MORTALITY WKLY. REP., Dec. 8, 2006, at 1, 13 (“In
contrast to vaccination of children, no national program exists to support vaccine purchase and
infrastructure for vaccine delivery to uninsured and underinsured adults.”).
81. Hartman v. May, 151 So. 737 (Miss. 1934).
82. Id. at 739.
83. Booth v. Bd. of Educ., 70 S.W.2d 350 (Tex. Civ. App. 1934).
84. Id. at 353.
85. Id.
86. Sadlock v. Bd. of Educ., 58 A.2d 218, 220 (N.J. 1948).
87. Id.
88. Seubold v. Fort Smith Special Sch. Dist., 237 S.W.2d 884, 887 (Ark. 1951).
89. Id.
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Court held that parents had no legal right to refuse vaccination of their children.
The court removed children from the father’s custody, placed them with a
90
guardian, and ordered them to be forcibly vaccinated. The Arkansas court did
not recognize the validity of the children’s religious exemptions, and, in referring
to Jacobson, reasoned that “it is within the police power of the State to require
that school children be vaccinated against smallpox . . . . In fact, this principle is
91
so firmly settled that no extensive discussion is required.” The Arkansas
Supreme Court upheld the prosecutor’s charge of child neglect against the father
who refused to vaccinate his children on religious grounds.
Given such extreme deference to police powers for many decades, potential
plaintiffs did not challenge Jacobson directly. Potential plaintiffs opposing
vaccination mandates presumably considered direct challenges futile. Instead,
since the 1960s, when states began to compel children to receive six or more
vaccines in multiple doses, litigation has centered on exemptions. Forty-eight of
92
the fifty states provide for religious exemption from vaccination mandates.
Cases before courts have considered whether membership in an unrecognized
93
faith justifies religious exemption; whether exclusion of unvaccinated children
94
from school following a measles outbreak is justified; whether a parent’s
95
religious objections to vaccination are sincerely held; whether religious
96
exemptions violate the First Amendment establishment clause; and whether
state laws with no religious exemption violate the First, Fifth, and Fourteenth
97
Amendments. As the Arkansas case above illustrates, states sometimes punish
non-compliant parents harshly. Even when religious exemptions exist, courts
sometimes find parents liable for child neglect when they refuse to vaccinate
98
their children. Courts have mandated child removal and forced vaccination in
99
families that have asserted religious objections.
Courts have used Jacobson to justify results that the original decision did not
condone: vaccination mandates exclusively for children with no imminent
disease outbreaks and with serious penalties for noncompliance. Punishments
include loss of education, social isolation, parents’ loss of custodial rights, child90. Cude v. State, 377 S.W.2d 816 (Ark. 1964).
91. Id. at 819.
92. See Hodge & Gostin, supra note 22, at 874 n.233; States With Religious and Philosophical
Exemptions from School Immunization Requirements, supra note 47.
93. Brown v. Stone, 378 So.2d 218 (Miss. 1979).
94. Maricopa Cnty, Health Dep’t v. Harmon, 750 P.2d 1364 (Ariz. Ct. App. 1987).
95. LePage v. State (In re LePage), 18 P.3d 1177 (Wyo. 2001).
96. Boone v. Boozman, 217 F. Supp. 2d 938 (E.D. Ark. 2002); McCarthy v. Boozman, 212 F.
Supp. 2d 945 (E.D. Ark. 2002)
97. Workman v. Mingo Cnty. Bd. of Educ., 419 F. App’x 348 (4th Cir. 2011); Workman v.
Mingo Cnty. Schs., 667 F. Supp. 2d 679 (S.D. W. Va. 2009).
98. In re Christine M., 595 N.Y.S.2d 606 (Fam. Ct. 1992); In re Elwell, 284 N.Y.S.2d 924
(Fam. Ct. 1967).
99. Cude v. State, 377 S.W.2d 816, 821 (Ark. 1964).
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neglect sanctions against parents, and, even, forced vaccination. In Jacobson and
Zucht, the Supreme Court upheld mandates for one vaccine during airborne
epidemics. Courts have expanded the original Jacobson precedent dramatically.
4. The Advisory Committee on Immunization Practices (ACIP)
Although Jacobson today remains the landmark case on state compulsory
vaccination, the federal government began to assume the driving role in
immunization policy in the 1960s. Government experts within the Centers for
Disease Control and Prevention (CDC) adopted the goal of eradicating infectious
disease, establishing an infrastructure for a war against it. In 1964, the Advisory
100
Committee on Immunization Practices (ACIP) met for the first time.
This
organization, under the Public Health Service Act, was to “assist states . . . in the
prevention and control of communicable diseases; to advise states on matters
relating to the preservation and improvement of the public’s health; and to make
grants to states to assist in meeting the costs of communicable disease control
101
programs.”
ACIP remains the key decision-making body within the federal
government on childhood immunization policy.
ACIP’s charter requires it to advise the public about vaccines against
vaccine-preventable diseases. For children, the charter requires ACIP to create a
list of vaccines for federal subsidy. ACIP became the only federal entity to make
vaccination recommendations to the states for public health, and for children in
102
States today rely on ACIP’s recommendations for school
particular.
vaccination mandates. The federal government subsidizes vaccines on the ACIPrecommended list for indigent children, and manufacturers receive liability
103
protection for ACIP-recommended vaccines by statute.
ACIP meets several times each year and consists of fifteen nongovernmental expert advisers whom the Secretary of the Department of Health
104
and Human Services (HHS) appoints. In addition to fifteen voting members,
ACIP includes eight ex officio members who represent federal agencies with
responsibility for immunization programs and twenty-six non-voting
100. Vaccines Timeline: 50 Years of Vaccine Progress, CENTERS FOR DISEASE CONTROL &
PREVENTION (Oct. 19, 2006), http://www.cdc.gov/vaccines/pubs/vacc-timeline.htm.
101. See 42 U.S.C. § 217a (2006) (“The Secretary may . . . appoint such advisory councils or
committees . . . for the purpose of advising him in connection with any of his functions.”); ACIP
Charter: Authority, Objective, and Description, Authority, CENTERS FOR DISEASE CONTROL &
PREVENTION (Apr. 6, 2010), http://www.cdc.gov/vaccines/recs/acip/download/charter.pdf.
102. ACIP Charter: Authority, Objective, and Description, Authority, supra note 101 (ACIP is
tasked to “establish . . . and revise a list of vaccines for administration to children and adolescents .
. . along with schedules . . . .”).
103. See 42 U.S.C. § 300aa-6 (2006) (authorizing appropriations necessary to carry out the
statute’s provisions); see also 42 U.S.C. § 300aa-11 (providing liability protection for
manufacturers of vaccines).
104. ACIP Charter: Authority, Objective, and Description, Authority, supra note 101.
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representatives of liaison organizations. Under its charter, ACIP must have at
least one consumer or community representative—all the rest may be from public
105
health and medical specialties.
In other words, of the forty-nine people
charged to deliberate on national vaccine policy, only one must represent the
public.
From ACIP’s inception, Jacobson’s requirements and the federal
government’s mission for immunization pointed in two potentially different
directions. Jacobson justified state and local health officials to mandate vaccines
against contagious epidemics that posed an imminent danger to the entire
population. By contrast, ACIP, the new driver of national immunization policy,
aimed to prevent and control infectious disease and to fund state childhood
vaccination programs. ACIP’s mission does not reference Jacobson’s
requirements of self-defense, imminent danger, necessity, or local authorities’
discretion. Instead, the federal government created in ACIP an infrastructure to
prevent and control communicable diseases particularly among children through
compulsory vaccination. In 1965, one year after its inception, ACIP urged
the creation of a federal program to compensate victims of vaccine injury and to
relieve manufacturers of ordinary tort liability.106 ACIP recommended that this
would keep the vaccine market stable, keep vaccines affordable, and ensure
compensation to victims. Manufacturers and medical communities joined this
recommendation.107 Later, the American Academy of Pediatrics developed
detailed proposals for a compensation scheme that would also relieve doctors of
tort liability.108 Indeed, other developed countries had already adopted
governmental compensation schemes for vaccine injury in the 1970s and
1980s.109 In 1986, the United States Congress would adopt such a program.
5. The National Childhood Vaccine Injury Act of 1986 (NCVIA)
Congress enacted the National Childhood Vaccine Injury Act of 1986
(NCVIA) almost two decades after the ACIP first recommended a government
110
compensation scheme. In the intervening two decades, vaccine injury litigation
had become more commonplace, more costly and, therefore, more problematic to
manufacturers and doctors who administered vaccines. Manufacturers threatened
to leave the marketplace unless the federal government granted them tort liability
protection. Seeking to shield the relatively new childhood immunization
program, Congress held hearings, including testimony from the pharmaceutical
105. Id.
106. JAMES COLGROVE, STATE OF IMMUNITY: THE POLITICS
CENTURY AMERICA 192 (2006).
107. Id. at 193.
108. Id. at 208.
109. Id. at 193.
110. Pub. L. No. 99-660, 100 Stat. 3755.
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industry, doctors, and parents of vaccine-injured children. Through the NCVIA,
Congress sought to (1) create the infrastructure for a national immunization
111
112
program, (2) insulate industry and the medical profession from liability, (3)
113
and (4) promote safer
establish a program to compensate the injured,
114
vaccines.
The NCVIA outlined an ambitious agenda of research, production,
115
procurement, distribution, promotion and purchase of vaccines. It established
the National Vaccine Injury Compensation Program (VICP) for “vaccine-related
116
injury or death.”
In its legislative history, Congress made clear that
117
compensation was to be swift, generous, and nonadversarial. Congress enacted
the statute to compensate children who were injured while serving the public
118
good.
The Program requires the parents of vaccine-injured children to file first in
119
the VICP before they may file a lawsuit in any ordinary civil court. In other
words, the Program has original jurisdiction over all claims of childhood vaccine
injury from federally recommended vaccines. The Court of Federal Claims in
120
Washington, D.C. administers it. After filing in the VICP, however, petitioners
retain the right to go to civil court after rejecting a VICP decision or waiting a
121
specified period.
Congress intended to create an administrative program,
where families would establish injuries specified in the Vaccine Injury Table and
122
receive compensation.
When Congress passed the NCVIA, there were many recognized vaccine
injuries, including anaphylaxis, encephalopathy, paralytic polio, and other acute
123
complications, including death.
Almost all injuries on the Vaccine Injury
Table were to have occurred within thirty days of vaccination; most were to have
124
occurred within hours or a couple days of the vaccination. If petitioners met
the precise requirements of the specified injuries, then they would have a
125
presumption of compensation. For injuries that were not listed on the Table,
111. 42 U.S.C. § 300aa-2 (2006).
112. Id. § 300aa-11.
113. Id. § 300aa-10.
114. Id. § 300aa-27.
115. Id. § 300aa-2.
116. Id. § 300aa-10.
117. H.R. REP. NO. 99-908, at 3 (1986), reprinted in 1986 U.S.C.C.A.N. 6344.
118. Id.
119. See 42 U.S.C. §§ 300aa-2, -11(a)(2)(A).
120. Id. § 300aa-12.
121. Id. § 300aa-21.
122. Id. § 300aa-14; see Vaccine Injury Table, HEALTH RESOURCES & SERVICES ADMIN.,
http://www.hrsa.gov/vaccinecompensation/vaccinetable.html (last visited Dec. 3, 2011).
123. 42 U.S.C. § 300aa-14.
124. Id.
125. Id.
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however, petitioners would have to prove them based on a preponderance of the
126
evidence.
The VICP requires that petitioners sue HHS; petitioners may not sue
127
manufacturers or healthcare practitioners in the Program.
HHS is the
respondent for all vaccine injury claims in the VICP. The rationale for this
protection of industry was to ensure a stable childhood vaccine supply and to
128
The source of VICP compensation is the
keep vaccine prices affordable.
Vaccine Injury Trust Fund, a fund now containing more than $3.3 billion from an
129
excise tax of seventy-five cents on the sale of every vaccine.
Petitioners try cases in the VICP before Special Masters of the Court of
Federal Claims. Eight Special Masters act as finders of fact and law. There are no
130
jury trials. The VICP is meant to be informal, without reliance on the federal
131
rules of evidence and civil procedure. Congress intended this informality to
benefit the petitioners, and Congress expected that the overwhelming majority of
claims would be resolved administratively, where detailed rules of evidence
would not be necessary. The statute also requires that the Secretary of HHS
“undertake reasonable efforts to inform the public of the availability of the
132
Program.”
Petitioners are entitled to receive $250,000 in the event of a vaccine-related
133
death and a maximum amount of $250,000 for pain and suffering.
These caps
have not changed since 1986. The Act also provides for “reasonable attorney’s
fees and costs” for bringing a petition so that petitioners do not have to pay
lawyers out of pocket or out of the proceeds of a judgment, as they would have to
134
do in civil court under a contingency fee arrangement.
The NCVIA requires that claimants file petitions no more than “36 months
after the . . . first symptom or manifestation of onset or of the significant
135
This three-year statute of limitations is
aggravation of such injury.”
126. Id. § 300aa-13(a)(1).
127. Id. § 300aa-11(a).
128. See, e.g., Calandrillo, supra note 14, at 408 (“Vaccine manufacturers quickly learned
their lesson and threatened to halt production unless guaranteed indemnification by the federal
government. As a result, vaccine shortages ensued, prices skyrocketed, and Congress was forced
into action.” (footnote omitted)).
129. National Vaccine Injury Compensation Program, HEALTH RESOURCES & SERVICES
ADMIN., http://www.hrsa.gov/vaccinecompensation/index.html (last visited Nov. 9, 2011) (“The
Trust Fund is funded by a $0.75 excise tax on each dose of vaccine purchased (i.e., each disease
prevented in a dose of vaccine).”).
130. 42 U.S.C. § 300aa-11 (giving jurisdiction to the court of federal claims).
131. FED. CL. R. app. 8(b)(1) (“In receiving evidence, the special master will not be bound by
common law or statutory rules of evidence but must consider all relevant and reliable evidence
governed by principles of fundamental fairness to both parties.”).
132. 42 U.S.C. § 300aa-10.
133. Id. § 300aa-15.
134. Id.
135. Id. § 300aa-16.
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considerably shorter than most state tort statutes for injury to minors.
In perhaps the most significant part of the statute, the NCVIA restricts
vaccine manufacturers’ liability for those vaccines included on ACIP’s
recommended childhood schedule. Under its terms, starting in 1988, no vaccine
manufacturer was liable for a vaccine-related injury or death from one of the
ACIP-recommended vaccines “if the injury or death resulted from side effects
that were unavoidable even though the vaccine was properly prepared and was
136
accompanied by proper directions and warnings.”
In the 1990s, the number of cases of alleged vaccine injury filed with the
VICP jumped dramatically. Many families alleged that their children’s autism
resulted from certain vaccine antigens or from a mercury-containing vaccine
137
Thimerosal is
preservative, thimerosal, used in multi-dose vaccine vials.
138
approximately fifty percent mercury by weight.
Some of these families
successfully litigated in civil court, bypassing the VICP, arguing that the use of
thimerosal in infant vaccines was a defective design and outside VICP
139
jurisdiction.
In 2008, the Georgia Supreme Court held that civil courts must decide
140
design defect claims on a case-by-case basis. By contrast, in 2009, the Third
Circuit Court of Appeals held that all vaccine injuries allegedly due to design
141
defects of approved vaccines are by definition unavoidable under the NCVIA.
In 2011, the U.S. Supreme Court decided Bruesewitz v. Wyeth, a case interpreting
the VICP’s jurisdiction and resolving the split in interpretation between the
Supreme Court of Georgia and the Third Circuit Court of Appeals. The Court
addressed whether the NCVIA preempts all vaccine design defect lawsuits. In a
6-2 decision, the Supreme Court upheld the Third Circuit’s decision to disallow
142
These claims are thus barred in all courts, as the
all design defect claims.
VICP hears cases of individual injury only and is not equipped to hear design
defect claims.
In addition to broad liability protection, the NCVIA provides another
143
important protection to manufacturers. It provides that vaccine manufacturers
144
are not liable for damages if they fail to give direct warnings to patients.
136. Id. § 300aa-22(b)(1).
137. Autism Decisions and Background, U.S. CT. FED. CLAIMS, http://www.uscfc.uscourts.
gov/node/5026 (last visited Oct. 17, 2011).
138. Thimerosal in Vaccines, Thimerosal as a Preservative, U.S. FOOD & DRUG ADMIN.,
available
at
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/
ucm096228.htm (last updated Mar. 31, 2010).
139. See, e.g., Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008).
140. Id.
141. Bruesewitz v. Wyeth Inc., 561 F.3d 233 (3d Cir. 2009), aff’d, Bruesewitz v. Wyeth LLC,
131 S. Ct. 1068 (2011).
142. Bruesewitz, 131 S. Ct. 1068.
143. 42 U.S.C. § 300aa-22(c).
144. Id. (explaining that there is no liability “solely due to the manufacturer’s failure to
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Resting on the “learned intermediary” doctrine, which states that it is sufficient to
inform doctors of the risks, manufacturers bear no obligation to provide accurate
145
or complete information to those actually vaccinated.
Complementing manufacturers’ relief from disclosure requirements, another
provision exempts doctors from substantial federal disclosure requirements. It
tasks the HHS Secretary to “develop and disseminate vaccine information
146
materials.” It states that these materials should outline the benefits and risks of
147
vaccines and the availability of the VICP.
Doctors are obliged to provide
families with these information materials, but there is no penalty for failing to do
so.
Jacobson, Zucht, the ACIP, and the NCVIA all continue to play critical roles
in U.S. vaccine law and policy.
II. THE SUPREME COURT’S PERSONAL AUTONOMY JURISPRUDENCE
Since Jacobson, the Supreme Court has decided several cases about medical
intervention, bodily integrity, and sexual autonomy, further articulating what
constitutes valid individual liberty interests and the level of scrutiny a court must
apply to laws restricting them. These personal autonomy cases contrast starkly
with Jacobson’s legacy. While none of the cases addressing personal autonomy
touch on vaccination, they are relevant to how the Supreme Court would view a
challenge under the Fourteenth Amendment to a compulsory vaccination
mandate today.
A. Forced Sterilization, Contraception and Abortion
The first case where the Supreme Court invoked the term “strict scrutiny”
was Skinner v. Oklahoma, a 1942 case that struck down a state criminal statute
148
on forced sterilization.
Having only fifteen years earlier upheld forced
149
the
sterilization of a woman in a state mental institution in Buck v Bell,
Supreme Court rejected the Oklahoma statute on Fourteenth Amendment Equal
Protection grounds. In Buck v. Bell, the Court had relied on Jacobson to justify
the state’s exercise of the police power;150 in Skinner, the Court imposed a
151
heightened standard of review and found the state’s statute lacking.
The Court noted that “[m]arriage and procreation are fundamental to the
provide direct warnings to the injured party of the potential dangers resulting from the
administration of the vaccine”).
145. Id.
146. Id. § 300aa-26.
147. Id.
148. Skinner v. Oklahoma, 316 U.S. 535 (1942).
149. Buck v. Bell, 274 U.S. 200 (1927).
150. Id. at 204.
151. Skinner, 316 U.S. at 541.
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very existence and survival of the race. The power to sterilize, if exercised, may
152
The Court noted that the
have subtle, far-reaching and devastating effects.”
individual would be “forever deprived of a basic liberty” and “that strict scrutiny
of the classification which a State makes in a sterilization law is essential, lest
unwittingly or otherwise invidious discriminations are made against groups or
types of individuals in violation of the constitutional guaranty of just and equal
153
laws.” The Court found that the criminal statute was being applied unequally,
forcing sterilization on those convicted of theft but not on those convicted of
154
embezzlement—crimes which carried the same penalty. Justice Jackson, in his
155
concurrence, raised due process issues as well as those of equal protection.
The case suggests that when “fundamental civil rights” or “basic liberties” are at
stake, the Court must use strict scrutiny.
Although Buck v. Bell has never been formally overruled, the Colorado
Supreme Court summarized the contemporary view that “since Skinner,
commentators generally have concluded that compulsory sterilization laws, no
matter what their rationale, are unconstitutional in the absence of evidence that
compulsory sterilization is the only remedy available to further a compelling
156
governmental interest.”
In the 1960s and 1970s, the Court began to recognize liberty interests in
contraception and abortion decision-making. In 1961, the Court upheld a state
statute prohibiting access to contraception in Poe v. Ullman. Justice Harlan in
dissent outlined the balancing tests for “fundamental liberties” in the face of state
157
police powers. His reasoning strongly influenced the Court’s later decision in
Griswold v. Connecticut, which required the state to show that the contraceptive
restriction was “necessary, and not merely rationally related to, the
158
accomplishment of a permissible state policy.”
Harlan’s Poe dissent reasoned that due process guarantees are the “bulwarks
159
. . . against arbitrary legislation” that cannot be reduced to a simple formula.
He suggested that the balance between liberty and the demands of organized
society must be “a rational continuum which, broadly speaking, includes a
freedom from all substantial arbitrary impositions and purposeless restraints, and
which also recognizes . . . that certain interests require particularly careful
152. Id.
153. Id.
154. Id. at 541-42.
155. Id. at 546-47 (Jackson, J., concurring).
156. In re A.W., 637 P.2d 366, 368-69 (Colo. 1981).
157. Poe v. Ullman, 367 U.S. 497, 523-55 (1961) (Harlan, J., dissenting).
158. Griswold v. Connecticut, 381 U.S. 479, 497 (1965) (citing McLaughlin v. Florida, 379
U.S. 184 (1964)).
159. Poe, 367 U.S. at 541 (Harlan, J., dissenting) (citing Hurtado v. California, 110 U.S. 516,
532 (1884)).
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160
scrutiny of the state needs asserted to justify their abridgement.”
Justice
Harlan asserted that, when one is reviewing something that is a “basic liberty,”
such as the ability to procreate, there are limits to what the government may
impose. Justice Harlan argued that the contraception statute at issue should be
subjected to “strict scrutiny.”161
Although the right to personal autonomy in sexual conduct was highlighted
in Griswold, the decision also concerned the right to protect one’s health through
autonomous medical decisions without government interference. The movement
for birth control was in part to address the toll on women’s health from
162
The lack of a medical exception in the statute motivated the
pregnancy.
petitioners as well as liberty interests.
The Court in 1973 applied strict scrutiny to the right to an abortion during
the first trimester. Roe v. Wade declared that “the right to personal privacy
includes the abortion decision, but that this right is not unqualified.”163 The Court
found that a woman’s right to abort outweighed the state’s compelling interest in
protection of fetal life in the first trimester of pregnancy. Justice Rehnquist
dissented, arguing that the appropriate standard of review should be rational basis
and that the right to abortion was not deeply rooted in the country’s history.164
B. The Right to Make Medical Treatment Decisions
In the 1990s, the Court decided three cases on the limits of medical
autonomy: Cruzan v. Missouri, Washington v. Harper, and Glucksberg v.
Washington. While the Court did not adopt a strict scrutiny standard of review in
any of them, the majority did adopt intermediate scrutiny. These decisions
recognized individuals’ strong liberty interests in the right to make decisions
about bodily integrity and medical treatment.
In 1990, the Court directly addressed the right of an individual to refuse
unwanted medical intervention. In Washington v. Harper, the Court recognized a
prisoner’s “significant liberty interest in avoiding the unwanted administration of
antipsychotic drugs under the Due Process Clause of the Fourteenth
165
Amendment.”
The Court reversed the Supreme Court of Washington’s
application of a strict scrutiny standard and decided “whether the regulation is
166
reasonably related to legitimate penological interests.” It upheld the right of
the state to administer the drugs according to the procedures in the statute, but
160. Id. at 543 (citations omitted).
161. Id. at 548.
162. B. Jessie Hill, The Constitutional Right To Make Medical Treatment Decisions: A Tale of
Two Doctrines, 86 TEX. L. REV. 277, 307 (2007).
163. Roe v. Wade, 410 U.S. 113, 154 (1973).
164. See id. at 173-76.
165. Washington v. Harper, 494 U.S. 210, 221 (1990).
166. Id. at 223 (internal quotation mark omitted).
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acknowledged that forcible medical intervention was “a substantial interference
with that person’s liberty,” including the possibility of “serious, even fatal, side
167
effects.” The Court nonetheless upheld the statute as permissible largely based
on the security interest in the prison environment and deference to professional
medical judgment in the due process procedures.
Justice Stevens, joined by Justices Marshall and Brennan, dissented from the
majority about the liberty interest, the standard of review, and the quality of due
168
The dissent argued that the Court
process available under the statute.
“undervalued [the] respondent’s liberty interest. . . and has concluded that a
mock trial before an institutionally biased tribunal constitutes ‘due process of
169
law.’” It states that “a competent individual’s right to refuse such medication
170
is a fundamental liberty interest deserving the highest order of protection.” It
does not agree that the statute takes the inmate’s interests into account, and
argues that the policy “sweepingly sacrifices the inmate’s substantive liberty
interest to refuse psychotropic drugs, regardless of his medical interests, to
171
Justice Stevens argued that the
institutional and administrative concerns.”
policy was not narrowly drawn, that the decision makers were biased, and that
172
there was an insufficient showing of the state’s necessity to medicate.
The Cruzan decision followed just two months later, recognizing a
constitutionally protected liberty interest in refusing unwanted medical treatment
for an incapacitated individual in a coma. The Court upheld a state statute that
required that the evidence of the individual’s wishes in such circumstances be
173
“clear and convincing.” The Court noted the deep legal roots of the right to
refuse medical treatment. It noted that “[a]t common law, even the touching of
one person by another without consent and without legal justification was a
174
battery.” It quoted a Supreme Court decision from 1891 stating, “No right is
held more sacred, or is more carefully guarded by the common law, than the right
of every individual to the possession and control of his own person, free from all
restraint or interference of others, unless by clear and unquestionable authority of
175
law.”
Citing Justice Cardozo, the Cruzan majority wrote, “Every human being of
adult years and sound mind has a right to determine what shall be done with his
176
own body.” The Court noted that “[t]he informed consent doctrine has become
167. Id. at 229.
168. Id. at 237 (Stevens, J., dissenting).
169. Id.
170. Id. at 241.
171. Id. at 245-46.
172. Id. at 242-57.
173. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 280-81 (1990).
174. Id. at 269.
175. Union Pac. R.R. Co. v. Botsford, 141 U.S. 250, 251 (1891).
176. Cruzan, 497 U.S. at 269 (quoting Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92, 93
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177
firmly entrenched in American tort law.”
It found that the Court’s prior
decisions, including Jacobson, implied the constitutionally protected liberty
178
interest in refusing unwanted medical treatment.
Justice O’Connor’s concurrence was more emphatic about the liberty
interest to refuse unwanted medical treatment. She wrote, “[T]he liberty
guaranteed by the Due Process Clause must protect, if it protects anything, an
individual’s deeply personal decision to reject medical treatment, including the
179
artificial delivery of food and water.” She argued that “notions of liberty are
inextricably entwined with our idea of physical freedom and self-determination”
and that “the Court has often deemed state incursions into the body repugnant to
180
the interests protected by the Due Process Clause.”
Justice Scalia’s concurrence emphasized that the best way to address such
issues was through the Equal Protection Clause: “Our salvation is the Equal
Protection Clause, which requires the democratic majority to accept for
181
themselves and their loved ones what they impose on you and me.”
As in Washington v. Harper, Justices Brennan and Marshall dissented, with
Justice Blackmun joining them as well. They argued that Nancy Cruzan had a
“fundamental right to be free of unwanted medical care,” that her right was “not
outweighed by any interests of the state,” and that “improperly biased procedural
obstacles imposed by the Missouri Supreme Court impermissibly burden that
182
right.” The dissenters argued that because the Missouri statute impinged on a
fundamental right, the state interest had to be narrowly tailored. Fundamental
183
rights are to be protected even from “subtle governmental interference.” They
criticized the majority for recognizing a “general liberty interest,” but failed to
state explicitly what the “measure of that liberty interest or its application”
184
If, as Justice O’Connor conceded, a competent person has a right to
was.
185
refuse medical treatment, then it “must be fundamental,” they argued.
“[The]
freedom from unwanted medical attention is unquestionably among those
principles ‘so rooted in the traditions and conscience of our people as to be
186
ranked as fundamental,’” they concluded. While they acknowledged that the
individual’s liberty right is not absolute, Missouri’s general interest in protecting
187
life did not outweigh Cruzan’s parents’ petition to end hydration and nutrition.
(1914)).
177. Id.
178. Id. at 278.
179. Id. at 289 (O’Connor, J., concurring).
180. Id. at 287.
181. Id. at 300 (Scalia, J., concurring).
182. Id. at 302 (Brennan, J., dissenting).
183. Id. at 304.
184. Id.
185. Id.
186. Id. at 305 (quoting Snyder v. Mass., 291 U.S. 97, 105 (1934)).
187. Id. at 313.
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Justice Stevens wrote a separate, forceful dissent. He characterized the
state’s interest as an “abstract, undifferentiated interest in the preservation of
188
life,” that overwhelms the best interests of Nancy Cruzan.
He argued that
Cruzan’s parents’ rights should prevail, and that the state should not substitute its
189
decisions for theirs. He argued that the “sanctity, and individual privacy, of the
human body is obviously fundamental to liberty. Every violation of a person’s
190
body is an invasion of his or her liberty.” He argued that “lives do not exist in
abstraction from persons, and to pretend otherwise is not to honor but to
191
desecrate the State’s responsibility for protecting life.” While the majority did
not join his view, the Court’s range of opinion had shifted towards greater
recognition of the liberty interest.
In 1997, the Court decided Glucksberg v. Washington, unanimously holding
192
that there was no right to assisted suicide. Nevertheless, the Court reaffirmed
its line of cases finding a liberty interest in the Due Process Clause and requiring
heightened protection against government interference. The Court reviewed the
interests in marriage, procreation, education, contraception, bodily integrity and
193
abortion. It stated that “we have also assumed, and strongly suggested, that the
Due Process Clause protects the traditional right to refuse unwanted lifesaving
194
medical treatment.” The Court contrasted its decision in Cruzan, holding that
the common law had long recognized the right to refuse unwanted medical
treatment, with Glucksberg, where it found the right to assisted suicide was not
deeply rooted.
Justice Stevens in his concurrence wrote that the right to refuse treatment
comes not only from the common law, but also from the more fundamental rights
to bodily integrity and dignity. He agreed with the Court’s conclusion, but would
195
have applied strict scrutiny.
C. The Right to Autonomy in Sexual Relations
In 2003, the Court affirmed a heightened standard of review for the liberty
196
interest in an individual’s sexual autonomy. In Lawrence v. Texas, the Court
188. Id. at 331 (Stevens, J., dissenting).
189. Id. at 337.
190. Id. at 342.
191. Id. at 356-57.
192. Washington v. Glucksberg, 521 U.S. 702, 705-06 (1997).
193. Id. at 719-20 (citing Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833 (1992)
(abortion); Loving v. Virginia 388 U.S. 1 (1967) (marriage); Griswold v. Connecticut, 381 U.S.
479 (1965) (marital privacy, contraception); Rochin v. California, 342 U.S. 165 (1952) (bodily
integrity); Skinner v. Oklahoma, 316 U.S. 535 (1942) (having children); Pierce v. Society of
Sisters, 268 U.S. 510 (1925) (educational choice)).
194. Id. at 720.
195. Id. at 741-43 (Stevens, J., concurring).
196. Lawrence v. Texas, 539 U.S. 558 (2003).
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found a Texas statute criminalizing homosexual sodomy unconstitutional. The
majority found that individuals enjoy heightened liberty protection from
government intrusion in their private dwellings and personal autonomy. The
Court overruled its prior decision in Bowers v. Hardwick, supporting its reversal
with the Court’s precedents applying intermediate scrutiny in Casey v. Planned
Parenthood, an abortion rights case, and in Romer v. Evans, a discrimination case
197
on the basis of sexual orientation. The majority argued that Justice Stevens’s
198
dissent in Bowers should have been the majority decision. By contrast, Justice
O’Connor wrote that she found the Texas statute unconstitutional only on equal
protection grounds. She cited Justice Jackson on the Equal Protection Clause:
The framers of the Constitution knew, and we should not forget
today, that there is no more effective practical guaranty against
arbitrary and unreasonable government than to require that the
principles of law which officials would impose upon a minority
be imposed generally. Conversely, nothing opens the door to
arbitrary action so effectively as to allow those officials to pick
and choose only a few to whom they will apply legislation and
thus to escape the political retribution that might be visited upon
them if larger numbers were affected.199
Justices Scalia, Rehnquist and Thomas dissented, arguing that the majority
200
applied “an unheard-of form of rational-basis review.” The dissent argued that
no fundamental right had been impinged; that there was a rational relationship
with a legitimate state interest; and that neither due process nor equal protection
201
of the law were violated. Justice Thomas added in a separate dissent that while
the Texas statute was “uncommonly silly,” there was no constitutional basis for
202
protection of the right to personal autonomy.
***
Thus since the 1940s, the Supreme Court has applied intermediate or strict
scrutiny to cases about sterilization, abortion, medical treatment, and sexual
autonomy. Yet, it has never revisited compulsory vaccination since 1922, and has
not treated the issue in any depth since 1905. Based on the review of recent
personal autonomy cases, it seems likely that the Supreme Court would apply at
least an intermediate level of scrutiny to a state vaccination mandate case, even
though Jacobson required only a rational basis test.
197. Id. at 573-74.
198. Id. at 578.
199. Id. at 585 (citing Ry. Express Agency, Inc. v. New York, 336 U.S. 106, 112-13 (1949)).
200. Id. at 586.
201. Id. at 605.
202. Id. at 605-06.
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The Supreme Court today has two distinct and somewhat contradictory lines
of cases that relate to vaccination mandates—one focused on public health and
the limits of individual liberty and the other focused on the individual’s
fundamental claims to bodily integrity and autonomy. Both lines of cases have
potential life-and-death implications for individuals and society.
The contours of the vaccine issue have changed fundamentally since the
early 1900s. Now at issue are thirty to forty-five preventive vaccinations whose
administration start on the day of birth and which are compelled almost
exclusively on children. It is possible that the Supreme Court may be called on in
the foreseeable future to decide a case about the constitutionality of vaccination
mandates.
III. A HYPOTHETICAL CHALLENGE TO A HEPATITIS B VACCINATION MANDATE
FOR PRESCHOOL CHILDREN
Forty-seven states impose hepatitis B vaccination mandates for daycare and
203
school attendance, or both.
New York’s public health law on school
immunizations is representative, stating that a “school” includes “any public,
private or parochial child caring center, day nursery, day care agency, nursery
204
school, kindergarten,” and defining “child” as “any person between the age of
205
two months and eighteen years.” According to the statute, every child must
receive the federally recommended doses of the hepatitis B vaccine, and several
other vaccines, for school admission. “No principal, teacher, owner or person in
charge of a school shall permit any child to be admitted to such school, or to
attend such school, in excess of fourteen days, without the certificate [of
206
immunizations].”
The statute provides for the right of medical exemption if the required
207
immunizations “may be detrimental to the child’s health.”
And it grants the
right to religious exemption to parents who object to their child’s immunization
due to “genuine and sincere religious beliefs which are contrary to the practices
208
herein required.” New York State does not afford individuals a philosophical
or personal belief exemption to vaccination. It also requires the vaccination of
209
children who do not attend school and have no valid exemptions.
Are hepatitis B vaccination mandates for preschool aged children under the
age of six constitutional under the Fourteenth Amendment Due Process and
203. Hepatitis B Prevention Mandates for Daycare and K-12, supra note 2 (showing that only
Alabama, Montana, and South Dakota have no hepatitis B mandates for daycare or school).
204. N.Y. PUB. HEALTH LAW § 2164(1)(a) (Consol. 2011).
205. Id. § 2164(1)(b).
206. Id. § 2164(7)(a).
207. Id. § 2164(8).
208. Id. § 2164(9).
209. Id. § 2164(8-a).
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Equal Protection Clauses? Consider the hypothetical challenge of parents seeking
to place their son in a preschool in New York City that requires compliance with
the hepatitis B mandate. Assume that the parents of the three-year-old boy
complied with all other vaccination mandates but refused this medical
intervention against a disease that poses a negligible risk to their son and his
classmates. They also believe that the vaccine itself carries irrational risks
210
The child is ineligible for a religious
without any countervailing necessity.
exemption because the family does not oppose the mandate on religious grounds.
They oppose the mandate because it is unreasonable, arbitrary, oppressive, and
against the child’s best interests, concerns that Jacobson squarely addressed.
Imagine that they challenged the validity of the New York State regulation
under the Fourteenth Amendment Due Process and Equal Protection Clauses.
The New York State trial and appellate courts upheld the mandate but the New
York Court of Appeals, the state’s highest court, reversed and held that the
hepatitis B vaccination mandate violated the Fourteenth Amendment Due
Process Clause following the Supreme Court’s precedents in Jacobson, Harper,
Cruzan, and Glucksberg. New York State petitioned for certiorari and the U.S.
Supreme Court granted it.
How might the Supreme Court balance the interests of the state and young
child? The Court would have to look to Jacobson, Zucht, and the Court’s most
recent precedents on personal autonomy. But before turning to how the Court
might decide, the Article reviews background about the disease itself, federal
policy recommendations, and hepatitis B vaccination mandates that commenced
in the 1990s. The Article will then return to the hypothetical challenge.
A. Hepatitis B Disease, Federal Policy, Vaccination Mandates and Public
Response
The CDC provides the following information about hepatitis B disease:
Hepatitis B is a contagious liver disease that results from
infection with the hepatitis B virus. It can range in severity from
a mild illness lasting a few weeks to a serious, lifelong illness.
Hepatitis B is usually spread when blood, semen, or another
body fluid from a person infected with the hepatitis B virus
enters the body of someone who is not infected. This can happen
through sexual contact with an infected person or sharing
needles, syringes, or other drug-injection equipment. Hepatitis B
can also be passed from an infected mother to her baby at
birth.211
210. See infra notes 211-258 and accompanying text.
211. Hepatitis B Information for the Public, CENTERS FOR DISEASE CONTROL & PREVENTION,
http://www.cdc.gov/hepatitis/B (last updated Mar. 12, 2009).
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While the ACIP notes that transmission through saliva is possible, it
suggests that nonsexual interpersonal contact must occur over an extended
period, such as living with a chronic hepatitis B infected person in the same
212
household. Official CDC and ACIP materials do not suggest that transmission
between young children through routine contact poses a significant threat.
1. The 1982 and 1988 ACIP Recommendations
In 1982, ACIP recommended the hepatitis B virus (HBV) vaccine only for
those people “at substantial risk of HBV infection who are demonstrated or
213
judged likely to be susceptible.” ACIP noted that the United States is “an area
of low HBV prevalence,” and that “the estimated lifetime risk of HBV . . . [is]
214
approximately 5% for the population as a whole.”
ACIP recommended the
vaccine only for “higher risk groups”: health-care workers, infants born to
mothers infected with hepatitis B, and people likely to be in sexual or “needle
215
In other words, ACIP
stick” contact with those infected with hepatitis B.
recommended the vaccine to healthcare workers, drug addicts, homosexual and
heterosexual adults with multiple sexual partners, and infants of infected
mothers.
In 1988, ACIP issued another statement about the vaccine, calling for
screening of all pregnant women to identify which mothers were infected—it
estimated 16,500 mothers per year—and recommended that their infants be
vaccinated. Without vaccination, ACIP estimated that 3500 infants would
216
become chronic hepatitis B carriers. It stated:
Prenatal screening of all pregnant women would identify those
who are HBsAg-positive [hepatitis B surface antigen positive]
and thus would allow treatment of their newborns with hepatitis
B immune globulin (HBIG) and hepatitis B (HB) vaccine, a
regimen that is 85%-95% effective in preventing the
development of the HBV chronic carrier state.217
212. Mast et al., supra note 80, at 5.
213. Ctrs. for Disease Control & Prevention, Recommendation of the Immunization Practices
Advisory Committee (ACIP) Inactivated Hepatitis B Virus Vaccine, 31 MORBIDITY & MORTALITY
WKLY. REP. 317 (1982), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00001116.
htm.
214. Id.
215. Id.
216. Ctrs. for Disease Control & Prevention, Recommendations of the Immunization Practices
Advisory Committee Prevention of Perinatal Transmission of Hepatitis B Virus: Prenatal
Screening of All Pregnant Women for Hepatitis B Surface Antigen, 37 MORBIDITY & MORTALITY
WKLY. REP. 342 (1988), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00000036.
htm.
217. Id.
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COMPULSORY VACCINATION
Thus by 1988, ACIP had proposed a solution to address potential hepatitis B
transmission to approximately 3500 infants annually.
2. The 1991 ACIP Recommendation
In 1991, after the NCVIA was in effect, ACIP changed its recommendation
dramatically. Now, instead of characterizing the United States as “an area of low
218
HBV prevalence” with certain high risk groups, ACIP describes the situation
this way: “The acute and chronic consequences of hepatitis B virus infection are
219
major health problems in the United States.” While acknowledging that “most
infections occur among adults and adolescents,” ACIP decided “immunization
with hepatitis B vaccine is the most effective means of preventing HBV infection
220
ACIP’s recommendation was a “comprehensive
and its consequences.”
strategy to eliminate transmission of HBV and ultimately reduce the incidence of
hepatitis B and hepatitis B-associated chronic liver disease in the United
221
States.”
To achieve this end, ACIP recommended hepatitis vaccination for all infants,
regardless of the mother’s infection status. It stated that “[h]epatitis B vaccine
should be incorporated into vaccination schedules for children. The first dose can
be administered during the newborn period, preferably before the infant is
discharged from the hospital, but no later than when the infant is 2 months of
222
age.”
The 1991 recommendation noted two types of licensed hepatitis B vaccines
in the United States, Merck’s Recombivax HB and GlaxoSmithKline’s EngerixB, both produced with new, genetically engineered recombinant DNA
223
technology. As to safety, the report stated that the vaccines “have been shown
to be safe,” “over 4 million adults have been vaccinated,” and that “many
224
children have received hepatitis B vaccine worldwide.” It noted however, that
225
“only a small number of children have received recombinant vaccine.” Indeed,
218. Recommendation of the Immunization Practices Advisory Committee (ACIP) Inactivated
Hepatitis B Virus Vaccine, supra note 213.
219. Ctrs. for Disease Control & Prevention, Hepatitis B Virus: A Comprehensive Strategy for
Eliminating Transmission in the United States Through Universal Childhood Vaccination:
Recommendations of the Immunization Practices Advisory Committee (ACIP), 40 MORBIDITY &
MORTALITY WKLY. REP., Nov. 22, 1991, at 1, 2, available at http://www.cdc.gov/mmwr/preview/
mmwrhtml/00033405.htm; see also ADVERSE EVENTS ASSOCIATED WITH CHILDHOOD VACCINES:
EVIDENCE BEARING ON CAUSALITY 211-35 (Kathleen R. Stratton et al. eds., 1994), available at
http://www.nap.edu/catalog/2138.html (addressing safety and reported adverse events for hepatitis
B vaccine administration).
220. Ctrs. for Disease Control & Prevention, supra note 219, at 3.
221. Id.
222. Id. at 12.
223. Id. at 6.
224. Id. at 10.
225. Id. at 11.
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the package inserts for Recombivax HB and Engerix-B indicated that the clinical
trials for the vaccines had been done on small groups of children, and gave scant
226
evidence that the trials had been done on newborn infants.
In addition to recombinant DNA, which had not been used previously on a
widespread basis, the hepatitis B vaccine administered at birth from 1990 to 2001
227
included 25 micrograms of the mercury-containing preservative thimerosal, or
12,500 parts per billion (ppb) of ethylmercury (because thimerosal is half
228
mercury by weight). Mercury is a recognized neurotoxin, with an amount as
229
low as 0.5 ppb able to destroy human neuroblastoma cells. The vaccine today
continues to contain 0.3 ppb thimerosal, or what the CDC denotes as a “trace”
230
amount.
Both approved vaccines also contain aluminum as an adjuvant to
226. Merck & Co., Recombivax HB: Hepatitis Vaccine, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110114
.pdf (insert for Recombivax HB). Merck’s Recombivax HB package insert currently provides the
following information about clinical trials that occurred before marketing: “In three clinical studies,
434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children
(up to 10 years of age) who were monitored for 5 days after each dose.” The insert does not state
the ages of the children or the proportion of the 147 subjects who were infants. It makes no mention
of newborns. See also GlaxoSmithKline, Engerix-B, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm224503.pdf
(insert for Engerix). GlaxoSmithKline (GSK) Engerix-B package insert provides this information:
“In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy
adults and children who were initially seronegative for hepatitis B markers, and healthy neonates.
All subjects were monitored for 4 days post-administration.” While GSK suggests that it did test
the vaccine in healthy newborns, it provides no number of them on which the vaccine was tested
nor does it clarify how many adults vs. how many children tested the vaccine.
227. See Thimerosal in Vaccines, Thimerosal as a Preservative, supra note 138.
228. NAT’L RESEARCH COUNCIL, TOXICOLOGICAL EFFECTS OF METHYLMERCURY 11 (2000)
(citing the Environmental Protection Agency’s guideline of 0.1 microgram per kilogram per day).
Thus a baby weighing approximately five kilograms at two months should not receive more than
0.5 micrograms of mercury on the day of a doctor’s visit. At the two-month visit, infants routinely
received 62.5 micrograms of mercury, or 125 times the EPA limit. Later studies suggested that “the
accepted reference dose should be lowered to between 0.025 and 0.06 micrograms per kilogram per
day,” meaning that the exposure at the two-month visit could be as high as 500, rather than 125,
times the recommended level. Steven G. Gilbert & Kimberly S. Grant-Webster, Neurobehavioral
Effects of Developmental Methylmercury Exposure, 103 ENVTL. HEALTH PERSP. 135 (1995).
229. Michael F. Wagnitz, Comment to Rahul K. Parikh, Fighting for the Reputation of
Vaccines: Lessons from American Politics, 121 PEDIATRICS 621 (2008), available at
http://pediatrics.aappublications.org/content/121/3/621/reply#pediatrics_el_36839.
230. Merck & Co., supra note 226; GlaxoSmithKline, supra note 226. In its list of excipients,
the CDC states: “Where thimerosal is marked with an asterisk (*) it indicates that the product
should be considered equivalent to thimerosal-free products. This vaccine may contain trace
amounts (<0.3 mcg) of mercury left after post-production thimerosal removal, but these amounts
have no biological effect.” Vaccine Excipient & Media Summary, Part 2: Excipients Included in
U.S. Vaccines, by Vaccine, CENTERS FOR DISEASE CONTROL & PREVENTION (Oct. 17, 2011),
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf. The
FDA considers Recombivax HB and Engerix-B products thimerosal-free. See Thimerosal in
Vaccines, U.S. FOOD & DRUG ADMIN., available at http://www.fda.gov/BiologicsBloodVaccines/
SafetyAvailability/VaccineSafety/ucm096228.htm (last updated Mar. 31, 2010) (“New pediatric
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COMPULSORY VACCINATION
231
boost immune response. Like mercury, aluminum is also a recognized toxic
232
233
substance and both metals potentially stimulate autoimmune syndromes.
On mercury’s long-time use as a vaccine preservative, Dr. George Lucier,
former Director of the National Toxicology Program of the National Institute of
Environmental Health Sciences, wrote:
I conclude that the justification for considering thimerosal . . . as
safe was inadequate and flawed, information on alternative
preservatives was ignored, the vaccine manufacturers ignored a
significant body of knowledge on health effects for at least 50
years and that the vaccine manufacturers did not conduct
necessary toxicology studies to establish safety.234
Besides the mercury safety concern, the Engerix-B and Recombivax HB
235
inserts do not address the safety of simultaneous vaccine administration. This
is notable because ACIP recommends that the second and third doses of hepatitis
B vaccine be given with the diphtheria, tetanus and pertussis vaccine, the
Haemophilus influenza type b vaccine, the pneumococcal vaccine and inactivated
poliovirus vaccine. Although it recommends simultaneous administration of
vaccines, ACIP does not require that childhood vaccines be clinically tested for
synergistic effects.
The Association of American Physicians and Surgeons filed a Freedom of
Information Act (FOIA) in 1999 to require information on the hepatitis B vaccine
preliminary safety data. It requested all safety data the CDC had prior to ACIP’s
236
It
1991 recommendation and the statistical model ACIP used to assure safety.
formulations of hepatitis B vaccines have been licensed by the FDA, Recombivax-HB (Merck,
thimerosal free) in August 1999 and Engerix-B (GlaxoSmithKline, thimerosal free) in January
2007.”).
231. Vaccine Excipient & Media Summary, Part 2: Excipients Included in U.S. Vaccines, by
Vaccine, supra note 230.
232. For neurotoxic effects of mercury, see Mercury: Human Health, ENVTL. PROTECTION
AGENCY, http://www.epa.gov/mercury/health.htm (last updated Oct. 1, 2010), and for aluminum,
see Division of Toxicology and Environmental Medicine ToxFAQs, AGENCY FOR TOXIC
SUBSTANCES & DISEASE REGISTRY (Sept. 2008), http://www.atsdr.cdc.gov/tfacts22.pdf.
233. E. Israel et al., Adjuvants and Autoimmunity, 18 LUPUS 1217 (2009); Lucette Pelletier et
al., Autoreactive T Cells in Mercury-Induced Autoimmunity: Ability To Induce the Autoimmune
Disease, 140 J. IMMUNOLOGY 750 (1988); Yehuda Shoenfeld & Nancy Agmon-Levin, ‘ASIA’ –
Autoimmune/Inflammatory Syndrome Induced by Adjuvants, 36 J. AUTOIMMUNITY 4 (2010); Ellen
K. Silbergeld et al., Mercury and Autoimmunity: Implications for Occupational and Environmental
Health, 207 TOXICOLOGY & APPLIED PHARMACOLOGY 282 (2005); L. Tomljenovic & C. A. Shaw,
Aluminum Vaccine Adjuvants: Are They Safe?, 18 CURRENT MEDICINAL CHEMISTRY 2630 (2011).
234. George W. Lucier, Thimerosal Is a Developmental Neurotoxicant, VERMONTERS FOR A
CLEAN ENV’T, http://www.vtce.org/mercury/lucier.pdf (last visited Nov. 9, 2011).
235. Merck & Co., supra note 226; GlaxoSmithKline, supra note 226.
236. The Hepatitis B Vaccine: Helping or Hurting Public Health: Hearing Before the
Subcomm. on Criminal Justice, Drug Policy, and Human Res. of the H. Comm. on Gov’t Reform,
106th Cong. 260 (1999) [hereinafter Hepatitis Hearings] (statement of Barbara Loe Fisher).
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237
has never received a response to its request made more than ten years ago.
By 1999, several scientific studies questioned the merits of the program to
vaccinate infants and newborns against hepatitis B. A 1996 article in the Journal
of Autoimmunity concluded, “[t]here is no doubt that the new recombinant
hepatitis B vaccine is different from mumps, measles, and rubella vaccines in its
238
A 1999 study in Epidemiology found a
ability to trigger autoimmunity.”
positive association between hepatitis B vaccination and liver disease in children
239
under age six.
The article “question[s] the logic of universal infant HB
240
vaccination in the United States.” It further states, “[t]here is no evidence . . .
supporting a protective effect of the HB vaccine against liver problems for the
241
general population of U.S. children.”
It concludes that “[e]ven if the HB
vaccine is effective for high risk groups, it does not indicate that it is also
242
effective for negligible risk groups.”
Another article reported, “In the case of Sweden, vaccinating over 100,000
children annually to ideally avoid 200 acute cases per year (mainly in drug
addicts) is not considered logical from a public health standpoint.”243 In other
words, in their calculus, it was irrational to vaccinate 1000 people to prevent
illness in 2. To compare this to the U.S. context, according to ACIP,
approximately 3500 infants were considered to be at risk of hepatitis in 1988 and
only 15% of them at most, or 525 infants, would not have been successfully
treated through hepatitis B immune globulin treatment and vaccination.
According to this information, the United States now vaccinates approximately 4
million infants per year to prevent approximately 525 cases of likely infection, or
about 10,000 infants to prevent likely illness in one child.
3. The 1999 ACIP Recommendation
In January 1999, ACIP expanded its hepatitis B vaccination recommendation
to include “all unvaccinated children aged 0-18 years and made hepatitis B
vaccine available through the Vaccines for Children program (VFC) for persons
237. Michael Belkin, The Vaccine Bubble and the Pharmaceutical Industry, in VACCINE
EPIDEMIC 139 (Louise Kuo Habakus & Mary Holland eds., 2011) (“We are still waiting for a
response today. Their failure to respond is damning. The implication is that the at-birth hepatitis B
vaccine recommendation was made without conducting proper safety studies in babies
beforehand.”).
238. Arnon Dov Cohen & Yehuda Shoenfeld, Vaccine-Induced Autoimmunity, 9 J.
AUTOIMMUNITY 699, 701 (1996).
239. Monica A. Fisher & Stephen A. Eklund, Hepatitis B Vaccine and Liver Problems in U.S.
Children Less Than 6 years Old, 1993 and 1994, 10 EPIDEMIOLOGY 337 (1999).
240. Id. at 339.
241. Id.
242. Id.
243. Sten Iwarson, Why the Scandinavian Countries Have Not Implemented Universal
Vaccination Against Hepatitis B, 16 VACCINE S56 (1998).
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COMPULSORY VACCINATION
244
aged 0-18 years who are eligible for VFC.”
This new policy expanded the
recommendation from just infants, covering about 4 million newborn infants per
year, to include all children through eighteen years, or approximately 76 million
children under age 18 who would each be recommended or required to get three
doses of the vaccine, or about 228 million doses. Under the VFC, all children
would be eligible for the vaccine; doctors could provide them to families without
245
charge because of federal and state subsidies.
Congress held hearings on the hepatitis B vaccine in May 1999. Doctors,
nurses, and parents of children injured by the hepatitis B vaccine testified. The
testimonies suggested that the vaccine’s side effects vastly outweighed the threat
246
of the disease to young children. The speakers expressed alarm at the apparent
rise in vaccine-related neurological disorders, deaths, and also at the decision247
making process that had led to hepatitis B vaccination without representation.
On July 8, 1999, the U.S. Public Health Service and the American Academy
of Pediatrics issued a joint statement recommending reduced infant exposure to
thimerosal, the mercury-containing preservative then used in the hepatitis B
vaccines. It specifically recommended that the birth dose of the vaccine should
be postponed in infants whose mothers were not hepatitis B positive until two to
248
six months of age. By mid-September 1999, however, when the hepatitis B
vaccines became available without thimerosal as a preservative, although it sill
contained “trace” amounts, the Public Health Service returned to its prior
recommendation to administer the first dose of hepatitis B vaccine to
249
newborns.
4. The 2005 ACIP Recommendation
In 2005, ACIP strengthened its hepatitis B recommendation further, stating
that “[a]ll delivery hospitals should implement standing orders for administration
of hepatitis B vaccination as part of routine medical care of all medically stable
244. Ctrs. for Disease Control & Prevention, Notice to Readers Update: Recommendations To
Prevent Hepatitis B Virus Transmission -- United States, 48 MORBIDITY & MORTALITY WKLY. REP.
33 (1999), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00056293.htm.
245. VFC: For Parents, CENTERS FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/
vaccines/programs/vfc/parents/default.htm (last updated Oct. 19, 2011) (“The Vaccines for
Children (VFC) Program offers vaccines at no cost for eligible children through VFC-enrolled
doctors.”).
246. Id.
247. Hepatitis Hearings, supra note 236, at 67 (statement of Michael Belkin).
248. Ctrs. for Disease Control & Prevention, Notice to Readers: Thimerosal in Vaccines: A
Joint Statement of the American Academy of Pediatrics and the Public Health Service, 48
MORBIDITY & MORTALITY WKLY. REP. 563 (1999), available at http://www.cdc.gov/mmwr/
preview/mmwrhtml/mm4826a3.htm.
249. Ctrs. for Disease Control & Prevention, Notice to Readers: Availability of Hepatitis B
Vaccine That Does Not Contain Thimerosal as a Preservative, 48 MORBIDITY & MORTALITY
WKLY. REP. 780, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4835a3.htm.
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250
infants weighing greater than or equal to 2000 g at birth.” This 2005 ACIP
report also noted that 15-50% of children “have low or undetectable
concentrations of anti-HBs (anti-HBs loss) [hepatitis B antibodies] 5-15 years
251
Although the report asserted that these children would
after vaccination.”
likely develop an antibody response upon exposure to HBV, it stated that the
children did not have documented immunity 5-15 years after vaccination.
Vaccination decisions are typically made on the basis of documented immunity.
In other words, at the age of sexual maturity when the children might themselves
benefit from the vaccine’s protection, its efficacy might not exist. This ACIP
report also rejected any purported association between the vaccine and multiple
sclerosis, chronic fatigue syndrome, neurologic disorders, rheumatoid arthritis,
type 1 diabetes, autoimmune disease, and sudden infant death syndrome that had
252
been described in the scientific literature.
Since 2005, further scientific investigation has suggested severe deleterious
health consequences for many children from the hepatitis B vaccine. A 2008
study associates hepatitis B vaccination of male newborns with autism diagnoses
253
from 1997-2002. Boys who received the birth dose of hepatitis B vaccine were
three times more likely to have parental report of autism than those who had not
254
received the hepatitis B birth dose. Gallagher and Goodman also found that the
three dose series of hepatitis B vaccines were associated with a nine-fold risk for
the vaccinated male newborns to have received early intervention or special
255
Data acquired from the CDC’s Vaccine Safety Datalink
education services.
under a Freedom of Information Act request also show an association between
vaccinations given before one month of age and autism and other neurological
256
disorders. A 2011 study of the hepatitis B vaccine on mice demonstrates that it
changes gene expression in the liver “which reflected subtoxic/adverse effects of
250. Ctrs. for Disease Control & Prevention, supra note 4, at 14.
251. Id. at 10.
252. Id. at 11.
253. Carolyn M. Gallagher & Melody S. Goodman, Hepatitis B Vaccination of Male Neonates
and Autism Diagnosis, NHIS 1997-2002, 73 J. TOXICOLOGY & ENVTL. HEALTH PART A 1665
(2010).
254. Id.
255. Carolyn M. Gallagher & Melody S. Goodman, Hepatitis B Triple Series Vaccine and
Developmental Disability in U.S. Children Aged 1-9 Years, 90 TOXICOLOGICAL & ENVTL.
CHEMISTRY 997 (2008).
256. A Brief Review of Verstraeten’s “Generation Zero” Vaccine Safety Datalink Study
Results, SAFE MINDS (2004), http://www.safeminds.org/research/library/GenerationZeroNotes.pdf;
Generation Zero, Thomas Verstraeten’s First Analyses of the Link Between Vaccine Mercury
Exposure and the Risk of Diagnosis of Selected Neuro-Developmental Disorders Based on Data
from the Vaccine Safety Datalink: November-December 1999, SAFE MINDS (2004)
http://www.safeminds.org/research/library/GenerationZeroPowerPoint.pdf (showing significant
correlation between early mercury exposures and autism, attention deficit disorder and sleep
disorders).
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COMPULSORY VACCINATION
257
the vaccine, especially in subtle liver injury.”
The authors attributed these
258
adverse effects to aluminum included in the vaccine as an adjuvant.
***
ACIP’s hepatitis B recommendations remain in effect today, with the first
dose recommended before hospital discharge, the second between one and two
259
months, and the third between six and eighteen months.
The hepatitis B
vaccines continue to contain aluminum and trace amounts of mercury. Fortyseven states make the hepatitis B vaccine mandatory for daycare and
260
preschool.
Critics continue to question the rationality of this vaccination mandate for
young children. First, newborns are at almost no risk of hepatitis B. According to
one doctor, when the U.S. population was around 248 million in 1991, there were
18,003 reported cases of hepatitis B viral illness in total—a national incidence of
261
0.007%. The number of cases of hepatitis B in the United States peaked in
1985 and started to decline because of improved precautions. In 1986, five years
before the 1991 ACIP Recommendation, only 279 cases of HBV infection were
262
By contrast, as of June
reported nationwide in children under age fourteen.
2006, there were 47,198 reports to the Vaccine Adverse Event Reporting System
(VAERS) describing complications following the administration of the hepatitis
B vaccine alone or with other vaccines. Of these, 23,406 were for children
fourteen years of age and younger. There were 909 death reports, of which 795
263
were under the age of fourteen. Dr. David Kessler, former commissioner of the
FDA, wrote in the Journal of the American Medical Association that “only about
264
suggesting that the
1% of serious adverse events are reported to the FDA,”
number of reported vaccine-related injuries may be underestimated.
In his 1999 testimony before the U.S. Congress, Mr. Belkin stated “only 54
265
cases of the disease were reported to the CDC in the 0-1 age group.” In the
same year, there were 1080 reports of adverse events reported in the 0-1 age
group, with 47 deaths. “Total VAERS hepatitis B reports for the 0-1 age group
257. Heyam Hamza et al., In Vivo Study of Hepatitis B Vaccine Effects on Inflammation and
Metabolism Gene Expression, MOLECULAR BIOLOGY REP., Mar. 17, 2011.
258. Id. at 6.
259. Recommended Immunization Schedule for Persons Aged 0 Through 6 Years—United
States, 2011, supra note 1.
260. See Hepatitis B Prevention Mandates for Daycare and K-12, supra note 2.
261. F. Edward Yazbak, The Hepatitis B Vaccine: What Went Wrong?, VACCINATION NEWS,
http://www.vaccinationnews.com/node/19957 (last visited Dec. 2, 2011).
262. Id.
263. Id.
264. David Kessler et al., Introducing MEDWatch: A New Approach to Reporting Medication
and Device Adverse Events and Product Problems, 269 JAMA 2765, 2765 (1993) (“Only about 1%
of serious events are reported to the FDA, according to one study.”).
265. Hepatitis Hearings, supra note 236, at 67 (statement of Michael Belkin).
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266
outnumber reported cases of the disease 20 to 1.”
If these reports in fact
reflected about 1% of total adverse reactions to the vaccine, as is conceivable, the
number of vaccine injuries to disease cases would be closer to 2000 to 1.
Mr. Belkin wrote:
Clearly, the interests of newborn babies were not represented on
the original panel that created this vaccination policy in 1991.
This vaccine has no benefit whatsoever for newborns, in fact it
wears off and they will need booster shots later in life when they
actually could get exposed to the disease. This is simply a case
of ravenous corporate greed and mindless bureaucracy teaming
up to overwhelm common sense.267
B. Financial Considerations in Hepatitis B Vaccination Mandates
The incidence of the disease was already diminishing when ACIP made its
1991 recommendation for newborns. While public health officials found it
challenging to vaccinate the at-risk adult populations, they were already
succeeding at vaccinating the at-risk infants of infected mothers. The rationale to
vaccinate the whole population of infants and young children in order to avoid
later incidence of the disease among the adult population was unproven. Infants
have been exposed to unknown risks for decades because of inadequate safety
science. The public health rationale for the hepatitis B vaccination of newborns,
infants, and young children is weak.
Financial motivation for the recommendation, however, is strong. The
vaccination of four million infants per year yields a substantial annual income
268
After the liability protections for
stream in the hundreds of millions of dollars.
industry and the medical profession were in place under the NCVIA, there were
substantial incentives for industry to work with government to introduce new
universal childhood vaccination mandates. NCVIA’s liability protection
mitigated the risks to industry from new, relatively untested vaccines. Infants in
the hospital after birth were available for medical intervention; additional doses
could be given at regularly scheduled pediatric visits. Given the way the courts
had interpreted Jacobson, few in government or industry would have feared a
266. Id.
267. Michael Belkin, Mindless Vaccination Bureaucracy, NAT’L VACCINE INFO. CTR.,
http://www.nvic.org/vaccines-and-diseases/Hepatitis-B/fatherstory.aspx (last visited Dec. 2, 2011).
268. See, e.g., BUSINESS INSIGHTS, THE VACCINE MARKET OUTLOOK: MARKET ANALYSIS OF
FUTURE GROWTH AND FUTURE PLAYERS BY SECTOR 39 tbl. 2.2 (2005). The report indicates that the
total U.S. revenue from hepatitis B vaccines in 2002 was $499.6 million and $468.1 in 2003. The
report does not disaggregate the revenue from infant, childhood, and adult hepatitis B vaccines or
from the hepatitis A vaccine, so the information is imprecise. The report does discuss, however, the
importance of compulsory vaccination to the vaccine market. “What is evident from th[ese] data is
that for a vaccine brand or category to perform well in the US market, it is essential that it is
included in the US immunization schedule.” Id. at 38.
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COMPULSORY VACCINATION
constitutional challenge. Indeed, two cases challenging the hepatitis B
269
vaccination mandates on religious grounds lost.
Part of Jacobson’s rationale for deference to state legislatures was their
representative nature; legislatures by their nature must take account of differing
views. If the legislature makes bad choices, the electorate can reverse those
choices and unseat the legislators through popular elections. But ACIP has
become the driving force behind vaccination mandates, a federal advisory body
270
with almost no public participation and no direct accountability to voters.
Because of this change in the locus of real decision making from legislators to
ACIP, there are far greater risks of conflicts of interest. ACIP advisers have
strong ties to industry, and financial and professional self-interest may outweigh
public health in their decision-making.
In 2000, a Congressional report on Conflicts of Interest in Vaccine Policy
Making identified notable conflicts of interest in the FDA and CDC advisory
271
bodies that make national vaccine policy. The report looked in detail at the
conflict of interests in the decision-making that led the FDA and CDC to approve
272
Merck’s Rotashield vaccine against rotavirus, an intestinal disease in infants.
Merck voluntarily withdrew Rotashield from the market thirteen months after its
273
launch due to serious adverse reactions.
The House Government Reform
Committee found numerous problems with Rotashield’s approval and vaccine
approvals in general:
advisers’ financial ties to vaccine manufacturers;
pervasive conflicts of interest;
little unbiased public participation;
advisers’ permitted stock ownership in companies affected by their
decisions;
advisers’ lack of disclosure of partisan expert witness work;
advisers who held vaccine patents approving vaccines for the same disease;
excessively long terms for committee members; and
liaison members’ undisclosed ties to vaccine manufacturers.274
There is little evidence that the CDC or FDA implemented any of
Congress’s recommendations. In 2008, eight years later, a government study of
269. Boone v. Boozman, 217 F. Supp. 2d 938 (E.D. Ark. 2002); McCarthy v. Boozman, 212
F. Supp. 2d 945 (E.D. Ark. 2002).
270. Hepatitis Hearings, supra note 236, at 67 (statement of Michael Belkin).
271. STAFF OF H. COMM. ON GOV’T REFORM, 106TH CONG., CONFLICTS OF INTEREST IN
VACCINE POLICY MAKING (Comm. Print 4024), available at http://www.nvic.org/nvicarchives/conflicts-of-interest.aspx (“In the interest of public health, Congress should revise existing
law to ensure that advisory committees contributing to vaccine policymaking are not unduly
affected by individuals with conflicts of interest.”).
272. Id.
273. Id.
274. Id.
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disclosure and conflict waivers at the CDC found that ninety-seven percent of
Special Government Advisers on CDC committees failed to disclose necessary
275
276
information, prompting criminal investigation of some.
Illustrative of the culture of conflicts of interest is the former Director of the
CDC, Dr. Julie Gerberding. One year after she stepped down as CDC Director,
277
she joined Merck as the Director of its Vaccine Group. During her tenure at
CDC, ACIP approved Merck’s Gardasil vaccine for human papilloma virus
278
(HPV) against cervical cancer.
Gardasil is the most expensive childhood
vaccine for the least prevalent disease that ACIP has ever approved and
recommended for universal use. There were well-documented conflicts of
interest in the Gardasil approval process. Since ACIP’s approval of the HPV
vaccine in 2007, the Vaccine Adverse Event Reporting System (VAERS) has
recorded 23,388 adverse events, including 103 deaths and 4777 individuals who
279
have not recovered after HPV vaccination.
The financial motivations in vaccine recommendations and mandates are
manifold. Industry offers ACIP members and other regulators career and
financial incentives. Industry offers financial inducements to state legislators who
make ACIP recommendations mandatory. States receive federal funding for
vaccination mandates. Doctors generate revenue from additional pediatric visits
275. DEP’T OF HEALTH & HUMAN SERVICES, OFFICE OF INSPECTOR GEN., OEI-04-07-00260,
CDC’S ETHICS PROGRAM FOR SPECIAL GOVERNMENT EMPLOYEES ON FEDERAL ADVISORY
COMMITTEES 16 (2009).
276. Id. at 23 n.69 (“The cases were forwarded to the OIG Office of Investigations because the
waivers were created pursuant to the criminal conflict-of-interest statute. The OIG Office of
Investigations reviewed information regarding these seven SGEs [special government employees]
and determined, largely as a result of CDC’s systemic lack of oversight of the ethics program for
SGEs identified in this report, that the actions of the seven SGEs did not rise to the level of criminal
violations of the conflict-of-interest statute.”).
277. Dr. Julie Gerberding Named President of Merck Vaccines, MERCK (Dec. 21, 2009),
https://merck.com/newsroom/news-release-archive/corporate/2009_1221.html.
278. Lauri E. Markowitz et al., Ctrs. for Disease Control & Prevention, Quadrivalent Human
Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices
(ACIP), 56 MORBIDITY & MORTALITY WKLY. REP., Mar. 12, 2007, available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm.
279. VAERS Data, VACCINE ADVERSE EVENT REPORTING SYS., http://vaers.hhs.gov/data/index
(last visited Dec. 2, 2011); see also Mark Blaxill, A License To Kill? Part 1: How a Public-Private
Partnership Made the Government Merck’s Gardasil Partner, AGE OF AUTISM (May 12, 2010, 5:35
AM),
http://www.ageofautism.com/2010/05/a-license-to-kill-part-1-how-a-publicprivatepartnership-made-the-government-mercks-gardasil-partner.html; Mark Blaxill, A License To Kill?
Part 2: Who Guards Gardasil’s Guardians?, AGE OF AUTISM (May 12, 2010, 5:37 AM),
http://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasilsguardians.html; Mark Blaxill, A License To Kill? Part 3: After Gardasil’s Launch, More Victims,
More Bad Safety Analysis and a Revolving Door Culture, AGE OF AUTISM (May 13, 2010, 5:45
AM), http://www.ageofautism.com/2010/05/a-license-to-kill-part-3-after-gardasils-launch-morevictims-more-bad-safety-analysis-and-a-revolvin.html; Online Access to the U.S. Government’s
VAERS Data, NAT’L VACCINE INFO. CTR., http://www.medalerts.org (last visited Dec. 2, 2011);
SANE VAX, INC., http://sanevax.org (last visited Dec. 2, 2011).
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and from the vaccinations themselves. A “more is better” vaccination policy has
many financial rewards, but does not necessarily lead to optimal or even rational
public health outcomes.
While observers have long noted conflicts of interest in vaccination
mandates, what is new is the potential scale of such conflicts. Because all school
children in the country are now subject to ACIP vaccination recommendations,
and state mandates based on them, conflicts of interests have greater impact than
when mandates were local affairs. The NCVIA, which centralized national
vaccination policy and created its infrastructure, facilitated vastly greater effect,
both good and bad.
C. Informed Consent, or Lack Thereof, to Hepatitis B Vaccination
The norm of informed consent in medicine requires doctors to provide
extensive information about the known risks of interventions to patients and to
280
allow them to make the ultimate decisions. Similarly, drug manufacturers are
required by law to provide accurate and complete information about drug risks
with their products. With respect to vaccines, however, these norms are
substantially relaxed. The NCVIA does not require doctors or vaccine
manufacturers to give complete warnings directly to the person or guardian of the
child being vaccinated. It requires that doctors give government-produced
information and requires that manufacturers provide proper warnings to doctors
281
only, who are considered to be “learned intermediaries.” Both industry and the
282
medical community lobbied for this lowered standard.
The NCVIA initially required more information than what parents receive
today. It specified ten items for CDC-drafted Vaccine Information Materials
283
(VIMs).
The initial versions were twelve pages long and required parental
signature. But pediatricians found the brochures were scaring parents and took
284
too much time. The American Academy of Pediatrics submitted legislation to
shorten the VIMs and Congress enacted the proposed changes in 1993. Instead of
ten information items, statements for parents now contained four: the benefits of
280. See, e.g., 61 AM. JUR. 2D Physicians, Surgeons, Etc. § 175 (2010) (“The doctrine of
informed consent imposes on a physician the duty to explain the procedure to the patient and to
warn him of any material risks or dangers inherent in all collateral therapy, so as to enable the
patient to make an intelligent and informed choice about whether or not to undergo the
treatment.”).
281. See, e.g., 28 C.J.S. Drugs and Narcotics § 128 (2010) (“Under the learned-intermediary
doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn
the patient, consumer or general public of the dangers involved with the product, but instead has a
duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the
manufacturer.”).
282. See COLGROVE, supra note 106, at 208-17.
283. 42 U.S.C. § 300aa-26(c) (2006).
284. Kristine M. Severyn, Jacobson v. Massachusetts: Impact on Informed Consent and
Vaccine Policy, 5 J. PHARMACY & L. 249, 270-71 (1996).
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the vaccine, the risks, one sentence about the VICP, and a reference to the CDC
for further information. Parents’ signatures were also eliminated. In an advisory
to doctors, the CDC wrote that the new VIMs “provide enough information that
285
The current
anyone reading the materials should be adequately informed.”
statements largely reassure parents that immunizations are safe and effective.
The current Hepatitis B Vaccine Information Statement provides the
following information about possible adverse events, claiming, “Hepatitis B is a
very safe vaccine. . . . Severe problems are extremely rare. Severe allergic
reactions are believed to occur about once in 1.1 million doses. A vaccine, like
any medicine, could cause a serious reaction. But the risk of a vaccine causing
286
serious harm, or death, is extremely small.”
By contrast, the hepatitis B vaccine package inserts provide long lists of
adverse events reported since the vaccine entered the market. A partial list of
adverse events reported for Engerix-B and Recombivax HB include anaphylaxis,
encephalitis, encephalopathy, paralysis, optic neuritis, multiple sclerosis, and
287
vasculitis.
Under the vaccine laws before 1986, these Vaccine Information Statements
would not have met minimum requirements for duty to warn. Some parents and
caregivers today also find the statements insufficient for rational decision-making
and informed consent. In Oregon, for instance, a bill has been introduced in the
state legislature to require physicians to give parents the hepatitis B vaccine
package insert and to have them consent in writing so that they can better
288
appreciate the risks. The citizen who took this initiative is the grandmother of
an infant who suffered a severe stroke after hepatitis B vaccination.
D. A Hypothetical Challenge to the New York State Hepatitis B Vaccine Mandate
for Preschoolers
So how would the Supreme Court today evaluate a challenge to New York
State’s hepatitis B vaccination mandate for preschoolers? The Court would likely
have to address the following issues based on its public health and personal
autonomy precedents.
1. Public Health Necessity
The Court would have to decide if there is a sufficient public health
necessity for the state to impose a preschool vaccination mandate. While the
285. Id. at 272.
286. Hepatitis B Vaccine:What You Need To Know, CENTERS FOR DISEASE CONTROL &
PREVENTION (July 18, 2007), http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-b.pdf.
287. Merck & Co., supra note 226; GlaxoSmithKline, supra note 226.
288. H.R. 2635, 76th Leg. Assemb., 2011 Reg. Sess. (Ore. 2011), available at http://gov.
oregonlive.com/bill/2011/HB2635.
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Court would be highly deferential, it would not grant a blank check. Although the
population as a whole may face the necessity to prevent and reduce the
prevalence of hepatitis B, the state would likely have to show that the necessity
specifically pertains to preschool children, the population to be burdened with
vaccination risks. As Dr. Jacobs has suggested, “The absence of linkage of a
disease to school activities should weigh heavily against a vaccination
289
As young children are presumably not engaged in high risk
requirement.”
transmission activities in preschool, on or off school premises, and there is
substantial evidence of potential medical harm to them based on science and
adverse vaccine event reporting, the state’s rationale of necessity is questionable.
2. Reasonable Means
The Court would have to assess if a vaccination mandate for preschoolers is
a reasonable means of addressing the threat of hepatitis B prevalence in the
broader society. Assume that the trial record revealed minimal clinical trials of
the vaccine on newborn infants and young children, including extremely short
290
monitoring periods. Assume that empirical evidence showed that the adverse
291
effects on this age group were greater than the risks posed by the illness.
Assume that the evidence showed that the vaccine’s efficacy wore off before
puberty and that preschoolers would require booster shots by age twelve to
292
While the state would point to the
maintain protection against the disease.
vaccine’s approvals by the FDA and ACIP as evidence of reasonableness, these
regulatory affirmations would not end constitutional inquiry. No jurisprudence of
which the author is aware suggests a presumption of reasonableness based on
agency approval.
3. Proportionality
The Court would have to assess whether the New York State vaccination
mandate is proportionate to the risk of disease. The state would have to show that
the risks of the disease to these children outweigh the risks of the vaccine. Most
likely, this would be very difficult to prove since incidence of the disease in the
preschool population is exceedingly low, yet the risks of adverse events from the
vaccine, including anaphylaxis, encephalopathy, and death, are well293
documented.
Furthermore, the public health rationale for the preschool
mandate was never primarily to reduce disease solely in this age group; rather, it
was to prevent risks to the entire population. It is unlikely that a court would be
289. Jacobs, supra note 34, at 193.
290. See supra notes 219-226 and accompanying text.
291. See supra notes 264-287 and accompanying text.
292. See supra notes 249-251 and accompanying text.
293. See supra notes 264 - 287 and accompanying text.
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willing to see the benefits to preschoolers as proportionate to the risks.
4. Harm Avoidance
The state would have to show that it provides for harm avoidance in its
hepatitis B mandate. In other words, it would have to demonstrate that it offers a
fair process for allowing medical exemptions to those who are at risk of injury or
death from the vaccine. A federal policy that recommends newborn vaccination
makes harm avoidance almost impossible, despite the fact that this is one of
Jacobson’s core requirements. How parents and doctors can avoid harm to a
newborn, who has virtually no medical history at birth, is hard to fathom except
by avoiding neonatal medical intervention altogether.
If (1) harm avoidance is an essential element to the state’s right to compel
vaccination (as Jacobson concluded), while (2) the administration of vaccines
may prevent any meaningful opportunity for harm avoidance because the infant’s
health status is unknown, then one may question whether the harm avoidance
criterion is met. While day of birth administration is not strictly required for
preschool attendance, the federal newborn recommendation tries to ensure that
294
the mandate is followed. In forty-seven states, the mandate is compulsory, and
for all infants, day of birth administration is recommended.
5. Non-discrimination
The Court would have to assess whether the vaccination mandate is nondiscriminatory. The state would argue that because the mandate is imposed on all
children in the same way, it is non-discriminatory. The parents would argue that
while Zucht upholds the right of a school district or state to impose vaccination
mandates on school children exclusively, that right is limited. If a vaccination
mandate is imposed without any rational relation to an educational purpose and is
based on population-wide necessity, its application may be arbitrary. If the
mandate is imposed solely on young children not primarily for their benefit, its
non-discrimination is questionable.
6. Liberty Interest in Due Process
The Court would have to assess whether parents, on behalf of their child,
294. Even though newborn administration of the hepatitis B vaccine is the standard of care,
forty percent of infants do not receive the birth dose. The mothers of these infants have higher
levels of income and education. Sean O’Leary, Risk Factors for Non-Receipt of Hepatitis B
Vaccine in the Newborn Nursery, Centers FOR DISEASE CONTROL & PREVENTION (Mar. 29, 2011,
11:15 AM), http://cdc.confex.com/cdc/nic2011/webprogram/Paper25335.html (“64,425 infants
were identified in the birth cohort, of whom 39,703 (61.6%) received a birth dose of HBV. . . .
Maternal characteristics such as higher income, higher education, and white race are associated
with non-receipt of the HBV during the perinatal period.”).
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have a liberty interest in being able to refuse an unwanted medical intervention.
The Court would likely acknowledge that any compulsory medical intervention,
including childhood vaccination, is “a substantial interference with that person’s
295
Having acknowledged that there are limits to the imposition of
liberty.”
unwanted medical treatment on a prisoner in Harper, the Court would likely
recognize an analogous liberty interest in a young child, which the child’s parents
exercise as guardians. The Court has repeatedly acknowledged that the right to
bodily integrity and to refuse unwanted medical treatment is deeply rooted in the
historical traditions of the United States. To be sure, vaccination against
infectious disease raises concerns different from a medical intervention that
would affect only the individual. But the deeply rooted interest in bodily integrity
exists in both contexts.
Jacobson acknowledged that the right to bodily integrity is not absolute but
that the state may not impermissibly burden that right. In Harper, the Court
recognized that the psychotropic drugs administered to a prisoner had to be
296
related to legitimate penological interests. While there is a distinction between
forcible injection of a prisoner and compelled injection of a preschooler, the
difference may be more theoretical than real. New York does not assert the right
to force vaccination on preschoolers, but it does assert the right to withhold
education and to require vaccination even if a child is homeschooled. The Court
would need to elaborate what constitutes an “impermissible burden” or “undue
burden” on the child’s liberty interest if it found that New York’s statute
interfered excessively with the child’s liberty interest.
Although courts have interpreted the required nexus between vaccination
mandates and education to be slight since Zucht, the Court would have to
examine whether some connection must exist between the disease and
transmission at school. In this case, the parents would argue that there is no
nexus, no threatened disruption of attendance, and a better available means, i.e.
screening mothers and vaccinating only those infants at risk of hepatitis B
infection. The state would argue that no nexus is required under expansive
interpretations of Jacobson.
Some of the Justices who participated in the personal autonomy decisions,
297
notably Justices Stevens, Brennan, Marshall, and Blackmun, would likely have
found the right to refuse vaccination to be a “fundamental” right and would have
subjected the state’s statute to “strict scrutiny.” These Justices likely would have
required that any state statute be narrowly tailored to obtain its compelling state
interest. As Justice Stevens concurred in Glucksberg, the right to refuse medical
treatment stems not just from the common law but also from the rights to bodily
295. Washington v. Harper, 494 U.S. 210, 229 (1990).
296. Id. at 223.
297. See supra notes 166-193 and accompanying text.
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298
integrity and dignity. Justice Stevens would likely have argued that the right to
299
bodily integrity is fundamental.
Subjected to strict scrutiny, the Court would likely find the vaccination
mandate unconstitutional. It is not clear that prevention of hepatitis B in the
preschool population is a compelling state interest, particularly when children are
at negligible risk, and there is no mandate for the adult population. Similarly, it is
not clear that a preschool mandate is narrowly targeted to achieve the state
interest of eradicating hepatitis B viral disease. Given poor evidence that
children’s immunity persists into puberty, it would be difficult for the state to
prove its case. Neither the federal government nor states have alleged that disease
transmission among preschoolers is a serious threat to public health.
It seems doubtful that there would be much readiness on the Court today to
adopt a strict scrutiny standard of review for a state vaccination mandate,
however. As Justice Scalia chided the majority in Lawrence v. Texas, the Justices
in the majority seemed to be more ready to “apply an unheard-of form of
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rational-basis review” than to declare a new interest “fundamental.”
Under
intermediate scrutiny or even rational basis, though, the state must demonstrate
that its mandate is rational. If the petitioner can prove that the vaccine causes
more harm than it prevents to this population, the mandate might not meet even
the rational basis test.
7. Liberty Interest in Equal Protection
A vaccination mandate for hepatitis B exclusively for young children, when
none is imposed on the adult population, raises equal protection issues when the
state’s objective is eradication of hepatitis B viral disease from the population as
a whole. While Zucht decided that schools may impose mandates for infectious
diseases, there are constitutional limits to what a legislative majority may impose
on any minority while leaving itself free of such constraints. While the state
might argue that children are at risk from the disease and benefit from its
compulsion, a child petitioner might argue that the adult population, which is
demonstrably at far greater risk, is exempted from a universal mandate in
violation of equal protection. Children may be the subject of discrimination if
they are selectively vaccinated for a disease from which they are at negligible
risk. While the hepatitis B mandate for children raises both due process and equal
protection concerns, one could imagine a Justice deciding that the regulation
meets a rational basis or intermediate scrutiny test but fails equal protection.
301
Justice O’Connor followed this rationale in Lawrence v. Texas.
298. Washington v. Glucksberg, 521 U.S. 702, 741-43 (1997) (Stevens, J., concurring).
299. Id.; Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 331-34 (1990) (Stevens, J.,
dissenting); Harper, 494 U.S at 237-39 (Stevens, J., concurring in part and dissenting in part).
300. Lawrence v. Texas, 539 U.S. 558, 586 (2003) (Scalia, J., dissenting).
301. Id. at 579-80.
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CONCLUSION
Although courts have interpreted Jacobson generously over the last century,
the decision itself and subsequent Supreme Court cases place real limits on
coercive medical interventions. In 1905, Justice Harlan made clear that
unreasonable, arbitrary or oppressive vaccination mandates could violate the
Fourteenth Amendment Due Process and Equal Protection Clauses. He foresaw
that mandates “might be exercised in particular circumstances and in reference to
particular persons in such an arbitrary, unreasonable manner, or might go so far
beyond what was reasonably required for the safety of the public, as to authorize
302
or compel the courts to interfere for the protection of such persons.”
The parents in this hypothetical argue that the hepatitis B mandate for
preschoolers is precisely such an abuse of the police power, going far beyond
what is reasonably required for the safety of the public. Later cases have widened
the scope of personal autonomy in medical decision-making. As Justice Stevens
warned in his Washington v. Harper dissent, a state’s “abstract, undifferentiated
interest in the preservation of life may in fact overwhelm real individuals’ best
interests.”
The hepatitis B vaccination mandate—not primarily for the benefit of young
children, and inadequately tested for their safety—has failed to honor young
children’s liberty, equal protection, and health. On the CDC’s record, there was
no clear medical rationale for introducing the vaccine for young children. The
apparent explanation for the dramatic turnaround in federal vaccination
recommendation was financial, not medical.
Professor Shapiro raises many important and interesting points in his
response, but his expansive analysis seems to bypass the precise reasons he finds
the hepatitis B vaccination mandate necessary for children under age six. What
is the basis, according to his constitutional logic, for compelling these children,
who are presumably not sexually active, drug using, or at risk of other routes of
infection, during early childhood? What important governmental objectives does
the mandate serve when these children’s artificial immunity will wane or be
nonexistent by the time they are potentially at risk of sexual or IV drug infection?
What distinguishes a hepatitis B mandate for preschoolers from the “spectacle of
unneeded coercion” that Professor Shapiro warns against?
In concluding, Professor Shapiro suggests that readers comply with
vaccination recommendations but be alert to potential conflicts of interest. But
this conclusion implies that readers get to make up their own minds–just what the
parents of preschoolers in forty-seven states do not get to do for the hepatitis B
vaccine.
Justice Jackson wrote in his concurrence in Skinner, “There are limits to the
302. Jacobson v. Massachusetts, 197 U.S. 11, 28 (1905) (citing Wis., Minn. & Pac. R.R. v.
Jacobson, 179 U.S. 287 (1900)).
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extent to which a legislatively represented majority may conduct biological
303
experiments at the expense of . . . a minority . . . .” It is time to reconsider
hepatitis B vaccination mandates for preschool children. If federal agencies,
advisory bodies, and state legislatures will not do so, then, as Justice Harlan
wrote in Jacobson, it may be time for “the courts to interfere for the protection of
such persons.”304
303. Skinner v. Oklahoma ex rel. Williamson, 316 U.S. 535, 546 (1942) (Jackson, J.,
concurring).
304
Jacobson, 197 U.S. at 28.
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